System, X-Ray, Mobile
FDA product code IZL · Class II (moderate risk) · 21 CFR 892.1720 · Radiology
237510(k) clearances
0PMA approvals
158recalls
Manufacturers
- Sedecal SA 17
- Minxray, Inc. 15
- General X-Ray, Inc. 11
- Samsung Electronics Co., Ltd. 8
- GE Medical Systems, LLC 8
- Carestream Health, Inc. 7
- DRGEM Corporation 6
- Source-Ray, Inc. 6
- Shimadzu Corp. 5
- Dynarad Corp. 5
- Siemens Medical Solutions USA, Inc. 5
- Philips Medical Systems (Cleveland) Inc 4
- Portable Power Systems, Inc. 4
- Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) 4
- Pro-Tronics, Inc. 4
- Solutions For Tomorrow AB 3
- Porta Ray, Inc. 3
- Oxos Medical, Inc. 3
- Poskom Co., Ltd. 3
- General Electric Co. 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260236 | XliteIZL · Traditional | Gemss Healthcare Co., Ltd. | 08/03/2026SE |
| K253058 | Portable DR Imaging SystemIZL · Traditional | Shantou Institute of Ultrasonic Instruments Co.… | 06/18/2026SE |
| K260085 | RAYMO Mobile X-ray System (Model: RAYMO)IZL · Traditional | DRGEM Corporation | 05/14/2026SE |
| K253185 | Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray SystemIZL · Traditional | Carestream Health | 03/11/2026SE |
| K253244 | AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini)IZL · Traditional | Poskom Co., Ltd. | 02/23/2026SE |
| K250976 | Airbile-100IZL · Traditional | Poskom Co., Ltd. | 12/19/2025SE |
| K251710 | Mobile X-ray unit (!M1)IZL · Traditional | Solutions For Tomorrow AB | 10/24/2025SE |
| K243864 | BONX805IZL · Traditional | Bontech Co., Ltd. | 09/12/2025SE |
| K251443 | PromoIZL · Traditional | DRGEM Corporation | 08/22/2025SE |
| K251223 | HnX-P1, HnX-PBIZL · Traditional | H&abyz Co., Ltd. | 08/04/2025SE |
| K250597 | REMEX Xcam6IZL · Traditional | Remedi, Inc. | 07/31/2025SE |
| K243473 | Prorad Atlas Ultraportable; Prorad Atlas Ultraportable PlusIZL · Traditional | Prognosys Medical Systems Private Limited | 07/29/2025SE |
| K250750 | INNOVISION-P5IZL · Traditional | Dk Medical Systems Co., Ltd. | 07/18/2025SE |
| K244049 | Europa (Alternative: AiRTouch) portable X-ray systemIZL · Traditional | Livermoretech, Inc. | 05/28/2025SE |
| K241980 | !M1IZL · Traditional | Solutions For Tomorrow AB | 05/06/2025SE |
| K241996 | Ultra 1040IZL · Traditional | Ecoray Co., Ltd. | 04/18/2025SE |
| K242015 | TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D)IZL · Traditional | DRGEM Corporation | 12/16/2024SE |
| K241505 | DRX-Revolution Mobile X-ray SystemIZL · Traditional | Carestream Health, Inc. | 12/10/2024SE |
| K240841 | Digital Radiography System (ManntiX B, ManntiX K)IZL · Traditional | Shenzhen Browiner Tech Co., Ltd. | 12/09/2024SE |
| K242515 | uDR 380i ProIZL · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 10/10/2024SE |
| K242651 | GM85IZL · Special | Samsung Electronics Co., Ltd. | 10/01/2024SE |
| K234108 | ERI Portable X-ray System (CVX-air); ERI Portable X-ray System (CVX-lite); ERI Portable…IZL · Traditional | Energy Resources International Co., Ltd. | 09/20/2024SE |
| K240009 | iQFlex ProIZL · Traditional | First Source, Inc. | 07/03/2024SE |
| K240284 | Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex…IZL · Traditional | Shenzhen Browiner Tech Co., Ltd. | 03/28/2024SE |
| K233678 | Radiography 7000 MIZL · Traditional | Philips Medical Systems Dmc GmbH | 02/14/2024SE |
| K232185 | Sm-IvIZL · Special | Sedecal., Sa. | 08/21/2023SE |
| K230581 | TOPA12 Portable X-ray UnitIZL · Traditional | Neuf, Inc. | 08/16/2023SE |
| K231577 | MOBILETT ImpactIZL · Traditional | Siemens Medical Solutions | 07/25/2023SE |
| K222896 | AirRayIZL · Traditional | Poskom Co., Ltd. | 12/20/2022SE |
| K222951 | Sm-VIZL · Abbreviated | Sedecal., Sa. | 11/21/2022SE |
| K222258 | Combined High Frequency X-ray SourceIZL · Traditional | Suzhou Powersite Electric Co., Ltd. | 11/01/2022SE |
| K222339 | uDR 380i ProIZL · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 09/30/2022SE |
| K222353 | GM85IZL · Traditional | Samsung Electronics Co., Ltd. | 09/29/2022SE |
| K221417 | CLAROX plus (Model: VX-100)IZL · Traditional | Vsi Co., Ltd. | 09/13/2022SE |
| K221803 | PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress.IZL · Special | Sedecal., Sa. | 07/18/2022SE |
| K213405 | MINE ALNU (Model: Mine 2.1)IZL · Traditional | Hdt Co., Ltd. | 07/10/2022SE |
| K221081 | iQFlex M Mobile X-ray System, iQFlex MD Mobile X-ray SystemIZL · Traditional | First Source, Inc. | 06/13/2022SE |
| K220700 | Heart5R-110 Portable X-Ray Machine, Heart3R-110 Portable X-ray MachineIZL · Traditional | Yian Medical Technology (Haining) Co., Ltd. | 05/04/2022SE |
| K220175 | GM85IZL · Traditional | Samsung Electronics Co., Ltd. | 04/21/2022SE |
| K220678 | APX-24 Portable X-ray SystemIZL · Traditional | Aspenstate, Inc. | 03/31/2022SE |
| K213568 | DRX-Rise Mobile X-ray SystemIZL · Traditional | Carestream Health | 03/23/2022SE |
| K212940 | Skanmobile, Skanmobile-DrIZL · Traditional | Skanray Technologies Limited | 03/04/2022SE |
| K213462 | EzRay M18 (Model: VMX-P400)IZL · Traditional | VATECH Co., Ltd. | 02/11/2022SE |
| K212654 | Micro C Medical Imaging System, M01IZL · Traditional | Oxos Medical, Inc. | 02/04/2022SE |
| K212515 | MOVIX DReamyIZL · Abbreviated | Stephanix | 11/03/2021SE |
| K212291 | PhoenixIZL · Traditional | Sedecal., Sa. | 09/14/2021SE |
| K212134 | Diagnostic X-ray System/PLX5200AIZL · Traditional | Nanjing Perlove Medical Equipment Co., Ltd. | 08/25/2021SE |
| K211383 | NFLK-2501 Portable X-ray UnitIZL · Traditional | Neuf, Inc. | 08/13/2021SE |
| K212144 | Remex KA6IZL · Traditional | Remedi Co., Ltd. | 08/03/2021SE |
| K211473 | Micro C Medical Imaging System, M01IZL · Traditional | Oxos Medical, Inc. | 06/04/2021SE |
| K211423 | RoverIZL · Special | Micro-X Limited | 05/21/2021SE |
| K210982 | AMX NavigateIZL · Special | Ge Medical Systems, LLC | 04/28/2021SE |
| K203782 | Nanox Cart X-ray SystemIZL · Traditional | Nano-X Imaging , Ltd. | 04/01/2021SE |
| K210479 | IMPACT and X-RangerIZL · Special | Minxray, Inc. | 03/19/2021SE |
| K203667 | EzRay M (Model: VMX-P300)IZL · Traditional | VATECH Co., Ltd. | 02/02/2021SE |
| K203658 | Micro C Medical Imaging System, M01IZL · Traditional | Oxos Medical, Inc. | 01/12/2021SE |
| K202350 | SR-1000 Portable DR Imaging System, SR-1000S Portable DR Imaging SystemIZL · Traditional | Shantou Institute of Ultrasonic Instruments Co.… | 01/06/2021SE |
| K202353 | SR-2300 Portable DR Imaging System, SR-2300S Portable DR Imaging SystemIZL · Traditional | Shantou Institute of Ultrasonic Instruments Co.… | 12/23/2020SE |
| K201488 | RoverIZL · Abbreviated | Micro-X , Ltd. | 07/17/2020SE |
| K200637 | SR-8100 Portable X-ray UnitIZL · Traditional | Shantou Institute of Ultrasonic Instruments Co.… | 07/09/2020SE |
| K201575 | CMDR 2C (Multiple Models)IZL · Special | Minxray, Inc. | 07/08/2020SE |
| K201340 | Aquila 320 D / Aquila 320 SIZL · Abbreviated | Vmi Tecnologias Ltda | 06/19/2020SE |
| K200976 | SR-8230, SR-8230S Portable X-ray UnitIZL · Traditional | Shantou Institute of Ultrasonic Instruments Co.… | 06/10/2020SE |
| K201124 | TOPAZ Mobile DR SystemIZL · Special | DRGEM Corporation | 05/19/2020SE |
| K193535 | EZER, Portable X-ray SystemIZL · Traditional | Livermoretech, Inc. | 05/07/2020SE |
| K200726 | AcuityPDRIZL · Traditional | Radmedix, LLC | 04/13/2020SE |
| K192936 | Soltus 500IZL · Special | Sedecal., Sa. | 11/15/2019SE |
| K192011 | PhoeniXIZL · Abbreviated | Sedecal., Sa. | 09/25/2019SE |
| K191884 | DR 100sIZL · Traditional | Agfa N.V. | 08/09/2019SE |
| K191813 | MobileDiagnost wDR 2.2IZL · Special | Sedecal., Sa. | 08/02/2019SE |
| K191451 | CMDR 2CW (Multiple models)IZL · Special | Minxray, Inc. | 07/03/2019SE |
| K191025 | DRX-Revolution Mobile X-ray SystemIZL · Special | Carestream Health, Inc. | 05/17/2019SE |
| K183292 | Topaz Mobile DR SystemIZL · Traditional | DRGEM Corporation | 05/15/2019SE |
| K182639 | MOBILETT Elara MaxIZL · Traditional | Siemens Medi Cal Solutions, Inc. | 03/15/2019SE |
| K183388 | JADE Mobile X-RayIZL · Traditional | DRGEM Corporation | 02/05/2019SE |
| K182207 | TR90BHIZL · Traditional | Minxray, Inc. | 12/14/2018SE |
| K182317 | AMADEO M-DR mini, AMADEO M-AX miniIZL · Traditional | Oehm Und Rehbein GmbH | 09/24/2018SE |
| K181874 | MX40 Mobile Digital X-ray SystemIZL · Traditional | Huestis Machine Corporation | 09/14/2018SE |
| K182234 | Optima XR240amxIZL · Special | Ge Medical Systems, LLC | 09/06/2018SE |
| K181626 | Digital Diagnostic Mobile X-ray SystemIZL · Traditional | Samsung Electronics Co., Ltd. | 07/20/2018SE |
| K173924 | DRX-Revolution Nano Mobile X-ray SystemIZL · Traditional | Carestream Health, Inc. | 02/05/2018SE |
| K173299 | Dragon X SPSL4HC, Dragon X SPSL8HCIZL · Special | Sedecal., Sa. | 01/26/2018SE |
| K173602 | Optima XR240amx, AutoGridIZL · Traditional | Ge Medical Systems, LLC | 01/12/2018SE |
| K173018 | MDR17 Mobile Direct Radiographic SystemIZL · Abbreviated | Del Medical, Inc. | 11/20/2017SE |
| K173187 | MobileDiagnost M50IZL · Traditional | Philips India Limited | 11/16/2017SE |
| K170607 | !M1IZL · Traditional | Solutions For Tomorrow AB | 07/17/2017SE |
| K170755 | DRX-Revolution Nano Mobile X-ray SystemIZL · Traditional | Carestream Health, Inc. | 06/21/2017SE |
| K171353 | CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), IntegrisIZL · Special | Minxray, Inc. | 06/07/2017SE |
| K171119 | GM85IZL · Traditional | Samsung Electronics Co., Ltd. | 05/12/2017SE |
| K170858 | FDR Aqro (Dr-Xd 1000)IZL · Traditional | Fujifilm Medical Systems U.S.A, Inc. | 04/24/2017SE |
| K163063 | UC-5000 Mobile X-RayIZL · Traditional | Source-Ray, Inc. | 12/12/2016SE |
| K162990 | Optima XR240amxIZL · Special | Ge Medical Systems, LLC | 11/15/2016SE |
| K162278 | Digital Diagnostic Mobile X-ray SystemIZL · Traditional | Samsung Electronics Co., Ltd. | 11/15/2016SE |
| K162687 | Paragon 2IZL · Traditional | Meridian Medical Systems, LLC | 10/21/2016SE |
| K161345 | RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIRIZL · Special | Sedecal., Sa. | 07/06/2016SE |
| K153059 | HF1202H PowerPlus Portable X-ray EquipmentIZL · Special | Minxray, Inc. | 02/02/2016SE |
| K143494 | ADX6000 Portable X-Ray System; iRayA6IZL · Traditional | Dexcowin Co., Ltd. | 10/05/2015SE |
| K151038 | EPX-Series Mobile X-ray SystemIZL · Traditional | Ecotron Co., Ltd. | 07/24/2015SE |
| K143537 | Sirius Starmobile tiaraIZL · Traditional | Hitachi Medical Systems America, Inc. | 03/06/2015SE |
| K150097 | GM60A-32S & GM60A-40SIZL · Traditional | Samsung Electronics Co., Ltd. | 02/19/2015SE |
| K142492 | GM60A-32S, GM60A-40SIZL · Traditional | Samsung Electronics Co., Ltd. | 12/17/2014SE |
| K141539 | Kubtec X250IZL · Traditional | Kub Technologies, Inc. | 10/29/2014SE |
| K142383 | Optima XR200amx, Optima XR220amxIZL · Special | Ge Medical Systems, LLC | 09/25/2014SE |
| K141895 | Mobilediagnost WDRIZL · Special | Sedecal., Sa. | 09/18/2014SE |
| K141885 | CMDR-2ST & CMDR-2SLWT Digital Portable X-RayIZL · Special | Minxray, Inc. | 09/18/2014SE |
| K140723 | Nomad MD 75K V Handheld X-Ray SystemIZL · Traditional | Aribex, Inc. | 08/19/2014SE |
| K122298 | Ajex 1200 H / Ajex 240H Mobile X-Ray GeneratorIZL · Traditional | Ajex Meditech., Ltd. | 03/28/2014SE |
| K122697 | Porta 100HFIZL · Traditional | Job Corporation | 10/05/2012SE |
| K121410 | Dragon LWIZL · Special | Sedecal., Sa. | 08/02/2012SE |
| K120062 | Drx-Revolution Mobile X-Ray SystemIZL · Traditional | Carestream Health, Inc. | 04/13/2012SE |
| K111912 | Mobilett MiraIZL · Special | Siemens Medical Solutions USA, Inc. | 09/19/2011SE |
| K101517 | Sedecal Mobile Digital Diagnostic X-RayIZL · Special | Sedecal., Sa. | 08/05/2011SE |
| K111725 | Mobilediagnost WDRIZL · Special | Sedecal., Sa. | 07/19/2011SE |
| K103476 | BRIVOXR285AMX, Optima XR200AMX, OPTIMAXR220AMXIZL · Traditional | Ge Medical Systems, LLC | 06/16/2011SE |
| K103522 | SedecalIZL · Special | Sedecal., Sa. | 01/26/2011SE |
| K103597 | Dx-D 100IZL · Traditional | Agfa Healthcare N.V. | 01/03/2011SE |
| K092713 | Spectre Wireless Encrypted Footswitch and Hand Switch SystemIZL · Traditional | Transamerican Medical Imaging | 07/16/2010SE |
| K100449 | Minxray Model CMDR-2SIZL · Traditional | Minxray, Inc. | 04/23/2010SE |
| K100400 | Prestodr PortableIZL · Special | Cmt Medical Technologies, Ltd. | 04/22/2010SE |
| K090655 | Portable X-Ray System, Model Powermax 1260IZL · Traditional | Source-Ray, Inc. | 07/14/2009SE |
| K090268 | Shimadzu Mobile X-Ray System Mobile Art EvolutionIZL · Abbreviated | Shimadzu Corp. | 06/30/2009SE |
| K090322 | Easy Moving Plus, Sm-Xxhf-YyIZL · Special | Sedecal., Sa. | 03/17/2009SE |
| K083048 | Neoray DR 2520 Digital Imaging SystemIZL · Traditional | Portavision Medical, LLC | 11/21/2008SE |
| K082627 | Minxray, Model CMDR-1S and CMDR-1S-MILIZL · Traditional | Minxray, Inc. | 11/07/2008SE |
| K080701 | Shimadzu Mobile X-Ray System Mobiledart EvolutionIZL · Abbreviated | Shimadzu Corp. | 05/14/2008SE |
| K080945 | FCR Go Portable Digital X-Ray SystemIZL · Traditional | Fujifilm Medical Systems U.S.A, Inc. | 04/18/2008SE |
| K072392 | Opdima Digital Mammographic X-Ray SystemIZL · Special | Siemens Medical Solutions USA, Inc. | 09/25/2007SE |
| K070634 | Soyee Portable X-Ray Unit, Model SY-HF-110IZL · Traditional | Soyee Product, Inc. | 07/11/2007SE |
| K071015 | Opdima Digital Mammographic X-Ray SystemIZL · Special | Siemens Medical Solutions USA, Inc. | 05/10/2007SE |
| K063262 | AMX4-50 and AMX4-31 Mobile Digital Diagnostic Radiographic SystemsIZL · Traditional | Virtual Imaging | 12/26/2006SE |
| K062472 | Optional Remote Control, Model RC-115, for Portable X-Ray System, Model SR-115IZL · Traditional | Source-Ray, Inc. | 10/31/2006SE |
| K061685 | PulseraIZL · Traditional | Philips Medical Systems North America Co. | 09/15/2006SE |
| K060566 | Minxray, Models HFP24 and HFP40IZL · Special | Mikasa X-Ray Co., Ltd. | 04/05/2006SE |
| K052897 | GE Definium Amx 700, Model Amx 700IZL · Special | General Electric Medical Systems | 11/08/2005SE |
| K052721 | Minxray, Model HF100H+IZL · Special | Minxray, Inc. | 10/27/2005SE |
| K052341 | Ajex 9015/135H Portable X-RayIZL · Traditional | Jpi America, Inc. | 10/07/2005SE |
| K052001 | Model SR-115 Portable X-Ray SystemIZL · Traditional | Source-Ray, Inc. | 08/11/2005SE |
| K043062 | Model SR-130-D Portable Digital X-Ray SystemIZL · Traditional | Source-Ray, Inc. | 12/13/2004SE |
| K043002 | Sedecal Mobile X-Ray Units with Digital DetectorIZL · Special | Sedecal., Sa. | 11/18/2004SE |
| K042866 | AMX5 and AMX5D Mobile X-Ray SystemsIZL · Traditional | Ge Healthcare Technologies | 11/02/2004SE |
| K042368 | Practix ConvenioIZL · Abbreviated | Philips Medical Systems North America Co. | 10/04/2004SE |
| K042361 | Digital Portable X-Ray Units, Model SP-HF-4.0 DIZL · Special | Sedecal USA, Inc. | 09/29/2004SE |
| K041922 | GE Tethered Portable Digital Radiographic DetectorIZL · Special | General Electric Co. | 07/28/2004SE |
| K041763 | Shimadzu Mobile X-Ray System MUX-100D SeriesIZL · Traditional | Shimadzu Corp. | 07/13/2004SE |
| K040046 | Minxray, Model HF120/60H PowerplusIZL · Special | Minxray, Inc. | 02/02/2004SE |
| K032628 | Portable X-Ray Unit, Models PXP-15/20/40HFIZL · Traditional | United Radiology Systems, Inc. | 02/02/2004SE |
| K033238 | Mobilette XP and Mobilett XphybridIZL · Special | Siemens Medical Systems, Inc. | 11/14/2003SE |
| K032280 | Siremobil Iso-C 3DIZL · Abbreviated | Siemens AG | 09/10/2003SE |
| K030494 | SR-130IZL · Traditional | Source-Ray, Inc. | 05/20/2003SE |
| K022337 | 3D Navigation Interface for Siremobile Iso-C 3DIZL · Special | Siemens Medical Solutions USA, Inc. | 08/13/2002SE |
| K021016 | AMX-4 Plus Mobile X-Ray SystemIZL · Traditional | GE Medical Systems | 06/17/2002SE |
| K020436 | Portable X-Ray Units; Models SP-HF-2.8 & SP-HF-4.0IZL · Abbreviated | Sedecal., Sa. | 02/22/2002SE |
| K012663 | Easy Moving Mobile X-Ray Unit (Model Sm-Hf)IZL · Traditional | Sedecal USA, Inc. | 08/31/2001SE |
| K012379 | PDX-2000 Portable Digital X-Ray SystemIZL · Traditional | Trex Enterprises Corp. | 08/16/2001SE |
| K010304 | MXR-2000 Mobile X-Ray UnitIZL · Traditional | Irom Imaging, Inc. | 02/12/2001SE |
| K002685 | Cordless Compact Mobile X-Ray SystemIZL · Abbreviated | Medison Radiology Systems, Inc. | 09/15/2000SE |
| K001517 | Shimadzu Mobile X-Ray System MUX-100 SeriesIZL · Abbreviated | Shimadzu Corp. | 06/27/2000SE |
| K992229 | MXU-125 or TMX-125IZL · Traditional | Trex Medical Corp. | 08/06/1999SE |
| K981466 | XR-910IZL · Traditional | Imaging Sciences Intl., Inc. | 07/14/1998SE |
| K973833 | Control, X-Ray Diagnostic, Generator, High Voltage, Assembly, Tube Housing Diagnostic…IZL · Traditional | Dynarad Corp. | 12/30/1997SE |
| K973712 | Minxray HF100H High Frequency Diagnostic X-Ray UnitIZL · Traditional | Minxray, Inc. | 12/12/1997SE |
| K972365 | Compact or Comp-XIZL · Traditional | Eurotec, S.R.L. | 12/12/1997SE |
| K972204 | Acu-Ray HF Series Portable X-Ray UnitIZL · Traditional | Sterne Equipment Co., Ltd. | 10/08/1997SE |
| K970234 | Sealed Lead Acid Battery PackIZL · Traditional | Portable Power Systems, Inc. | 05/02/1997SE |
| K955036 | Mobile X-Ray SystemIZL · Traditional | Shimadzu Corp. | 12/22/1995SE |
| K955095 | Sierra Battery Sealed Lead Acid Battery SystemIZL · Traditional | Sierra Battery, Inc. | 12/21/1995SE |
| K953404 | Osteo-Ray 100IZL · Traditional | Micro Focus Imaging, Inc. | 11/30/1995SE |
| K953292 | CP 100/30IZL · Traditional | Micro-Focus Imaging., Inc. | 11/22/1995SE |
| K944442 | General Electric Amx 110, Amx II and Amx 3IZL · Traditional | Pro-Tronics, Inc. | 03/14/1995SE |
| K945043 | Battery Pack #PMX120-18AIZL · Traditional | Portable Power Systems, Inc. | 01/20/1995SE |
| K945707 | Minxray HF80H High Frequency Diagnostic X-Ray UnitIZL · Traditional | Minxray, Inc. | 01/19/1995SE |
| K932106 | Mobilett Plus Mobile X-Ray SystemIZL · Traditional | Siemens Medical Solutions USA, Inc. | 09/14/1994SE |
| K941363 | PhantomIZL · Traditional | Dynarad Corp. | 07/20/1994SE |
| K931483 | Replacement Batery for GE AMX-4 Port. X-Ray Mach.IZL · Traditional | Portable Power Systems, Inc. | 02/17/1994SE |
| K932353 | HF-110AIZL · Traditional | Dynarad Corp. | 01/31/1994SE |
| K934818 | Hand Held Dental X-Ray DeviceIZL · Traditional | Dept. of the Army | 01/24/1994SE |
| K931279 | Acu-RayIZL · Traditional | Sterne Equipment Co., Ltd. | 11/03/1993SE |
| K930699 | M6-MIZL · Traditional | X-Cel X-Ray Corp. | 08/09/1993SE |
| K932355 | 9150A, 1100FIZL · Traditional | Dynarad Corp. | 08/03/1993SE |
| K932354 | 9170, 1170IZL · Traditional | Dynarad Corp. | 07/23/1993SE |
| K931200 | Battery Packs (Various Models)IZL · Traditional | Access / God Loves You | 07/13/1993SE |
| K930049 | Infrared Exposure Hand SwitchIZL · Traditional | Mid X-Ray, Inc. | 06/22/1993SE |
| K923359 | Port-XpIZL · Traditional | Mobile Dental Equipment Corp. | 04/07/1993SE |
| K924798 | Battery PackIZL · Traditional | Portable Power Systems, Inc. | 10/16/1992SE |
| K921116 | PX-100 Portable X-Ray GeneratorIZL · Traditional | Acoma Medical Imaging, Inc. | 10/05/1992SE |
| K921425 | SCD-105 and SCD-125 Capacitor Discharge Mobile X-RIZL · Traditional | Acoma Medical Imaging, Inc. | 08/27/1992SE |
| K910902 | VMX Mobile X-Ray SystemIZL · Traditional | GE Medical Systems | 09/09/1991SE |
| K912323 | The RemoteIZL · Traditional | Remote Technologies, Inc. | 09/06/1991SE |
| K911841 | Minxray P300 X-Ray SystemIZL · Traditional | Minxray, Inc. | 08/26/1991SE |
| K912400 | Mobile X-Ray Floor StandIZL · Traditional | Dntl Corp. | 08/09/1991SE |
| K902984 | G.E. Amx 110, Amx II and Amx 3 X-Ray UnitsIZL · Traditional | Electromek Diagnostic Systems, Inc. | 10/26/1990SE |
| K902610 | General Electric Amx 3IZL · Traditional | Pro-Tronics, Inc. | 07/02/1990SE |
| K894643 | RT-125 Rough Terrain Mobile X-Ray UnitIZL · Traditional | Lorad Medical Systems, Inc. | 12/14/1989SE |
| K894021 | Mobile X-Ray UnitIZL · Traditional | Ziehm International, Inc. | 09/01/1989SE |
| K893637 | MC125L-50 Shimadzu Mobile X-Ray SystemIZL · Traditional | Shimadzu Medical Systems | 07/20/1989SE |
| K891143 | General Electric Amx 110IZL · Traditional | Pro-Tronics, Inc. | 05/03/1989SE |
| K891142 | General Electric Amx IIIZL · Traditional | Pro-Tronics, Inc. | 05/01/1989SE |
| K890306 | Bcm-Arc 105 X-Ray Mobile UnitIZL · Traditional | B C Medical , Ltd. | 04/17/1989SE |
| K883092 | Bennett BCA-6 &BCA-9 Mobile C-Arm Unit/Radio/FlourIZL · Traditional | Bennett X-Ray Corp. | 10/13/1988SE |
| K875106 | Pb-A Lead-Acid Battery Conversion KitIZL · Traditional | Diagnostic Imaging Specialists Corp. | 02/22/1988SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2728-2026 Class II | Optima XR240amx, Mobile Digital Radiographic SystemGE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column… | GE Medical Systems, LLC | 06/05/2026Open, Classified |
| Z-2727-2026 Class II | Optima XR220amx, Mobile Digital-Ready Radiographic SystemGE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column… | GE Medical Systems, LLC | 06/05/2026Open, Classified |
| Z-2726-2026 Class II | Optima XR200amx, Mobile Digital-Ready Radiographic SystemGE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column… | GE Medical Systems, LLC | 06/05/2026Open, Classified |
| Z-1918-2026 Class II | Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71X-Ray generator may malfunction resulting in the X-Ray being inoperable. | Micro-X Ltd. | 03/27/2026Open, Classified |
| Z-0480-2026 Class II | GM85 Digital Mobile X-ray imaging System; Model Number: GM85;The four (4) M5 bolts that secure the Tube Head Unit to the end of the arm may loosen or fracture due to… | NeuroLogica Corporation | 10/07/2025Open, Classified |
| Z-0287-2026 Class II | SM_40HF_BDC3, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and… | Sedecal SA | 06/10/2025Open, Classified |
| Z-0286-2026 Class II | SM_40HF_BDC, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and… | Sedecal SA | 06/10/2025Open, Classified |
| Z-0285-2026 Class II | SM_40HF_B_D_VIR3.004, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and… | Sedecal SA | 06/10/2025Open, Classified |
| Z-0284-2026 Class II | SM_40HF_B_D_VIR3, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and… | Sedecal SA | 06/10/2025Open, Classified |
| Z-0283-2026 Class II | SHIMADZU RF.004, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and… | Sedecal SA | 06/10/2025Open, Classified |
| Z-0282-2026 Class II | SED URS LP, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and… | Sedecal SA | 06/10/2025Open, Classified |
| Z-0281-2026 Class II | RADPRO MOBILE, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and… | Sedecal SA | 06/10/2025Open, Classified |
| Z-0280-2026 Class II | Model Number SM-40HF-B-D-C; 40KW70CDEMO.005, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and… | Sedecal SA | 06/10/2025Open, Classified |
| Z-0279-2026 Class II | Model Number SM-40HF-B-D-C; 40KW.005, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and… | Sedecal SA | 06/10/2025Open, Classified |
| Z-0278-2026 Class II | Model Number SM-40HF-B-D-C; 40KW.002, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and… | Sedecal SA | 06/10/2025Open, Classified |
| Z-0277-2026 Class II | Model Number SM-40HF-B-D-C; 40KW, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and… | Sedecal SA | 06/10/2025Open, Classified |
| Z-0276-2026 Class II | Model Number SM-40HF-B-D-C; 40KW CANON READY.005, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and… | Sedecal SA | 06/10/2025Open, Classified |
| Z-0275-2026 Class II | Model Number SM-40HF-B-D-C; 40KW CANON READY, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and… | Sedecal SA | 06/10/2025Open, Classified |
| Z-0274-2026 Class II | Model Number SM-40HF-B-D-C; 40KW 80C, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and… | Sedecal SA | 06/10/2025Open, Classified |
| Z-0273-2026 Class II | Model Number SM-40HF-B-D-C; 40KW 70C READY, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and… | Sedecal SA | 06/10/2025Open, Classified |
| Z-0272-2026 Class II | Model Number SM-40HF-B-D-C; 40KW 70C EN, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and… | Sedecal SA | 06/10/2025Open, Classified |
| Z-0271-2026 Class II | Model Number SM-40HF-B-D-C; 40KW 70C, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and… | Sedecal SA | 06/10/2025Open, Classified |
| Z-0270-2026 Class II | Model Number SM-40HF-B-D-C; 40KW 55C/60C, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and… | Sedecal SA | 06/10/2025Open, Classified |
| Z-0269-2026 Class II | Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and… | Sedecal SA | 06/10/2025Open, Classified |
| Z-0268-2026 Class II | Model Number SM-40HF-B-D-C; 40KW 55G/60G, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and… | Sedecal SA | 06/10/2025Open, Classified |
| Z-0267-2026 Class II | Model Number SM-40HF-B-D-C; 40KW 55G, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and… | Sedecal SA | 06/10/2025Open, Classified |
| Z-0266-2026 Class II | Model Number SM-40HF-B-D-C; 40KW 55C/60C, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and… | Sedecal SA | 06/10/2025Open, Classified |
| Z-0265-2026 Class II | Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and… | Sedecal SA | 06/10/2025Open, Classified |
| Z-0264-2026 Class II | Model Number SM-40HF-B-D-C; 40KW 50G, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and… | Sedecal SA | 06/10/2025Open, Classified |
| Z-0263-2026 Class II | Model Number SM-40HF-B-D-C; 40KW 50C, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and… | Sedecal SA | 06/10/2025Open, Classified |
| Z-0262-2026 Class II | Sedecal Easy Moving Plus Model Number SM-50HF-B-D-C; 50KW 50G, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and… | Sedecal SA | 06/10/2025Open, Classified |
| Z-0261-2026 Class II | Model Number SM-40HF-Batt; 40KW ANALOG, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and… | Sedecal SA | 06/10/2025Open, Classified |
| Z-0260-2026 Class II | Model SM-40HF-B-D-C; 40KW 70C, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and… | Sedecal SA | 06/10/2025Open, Classified |
| Z-0259-2026 Class II | Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and… | Sedecal SA | 06/10/2025Open, Classified |
| Z-0258-2026 Class II | Model Number SM-40HF-B-D-C; 40KW 50G, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and… | Sedecal SA | 06/10/2025Open, Classified |
| Z-0257-2026 Class II | Model SM-40HF-B-D-C; 40KW - CANON READY, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and… | Sedecal SA | 06/10/2025Open, Classified |
| Z-0256-2026 Class II | Model SM-32HF-Batt; 32KW ANALOG, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and… | Sedecal SA | 06/10/2025Open, Classified |
| Z-0255-2026 Class II | Model Number SM-32HF-B-D-C; 32KW 50G, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and… | Sedecal SA | 06/10/2025Open, Classified |
| Z-0254-2026 Class II | Model Number SM-20HF-Batt; 20KW ANALOG, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and… | Sedecal SA | 06/10/2025Open, Classified |
| Z-0253-2026 Class II | Model Number 40KWMOBILE3.899, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and… | Sedecal SA | 06/10/2025Open, Classified |
| Z-0252-2026 Class II | Model Number 40KWFXPLUS-710CW.007, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and… | Sedecal SA | 06/10/2025Open, Classified |
| Z-0251-2026 Class II | Model Number 40KWFXPLUS-710CW, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and… | Sedecal SA | 06/10/2025Open, Classified |
| Z-0250-2026 Class II | Model Number 40KWFXPLUS.889, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and… | Sedecal SA | 06/10/2025Open, Classified |
| Z-0249-2026 Class II | Model Number 40KWFXPLUS.005, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and… | Sedecal SA | 06/10/2025Open, Classified |
| Z-0248-2026 Class II | Model Number 40KWFXPLUS.004, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and… | Sedecal SA | 06/10/2025Open, Classified |
| Z-0247-2026 Class II | Model Number 40KWFXPLUS.002, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and… | Sedecal SA | 06/10/2025Open, Classified |
| Z-0246-2026 Class II | Model Number 40KWFXPLUS, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and… | Sedecal SA | 06/10/2025Open, Classified |
| Z-0245-2026 Class II | Model Number 40KW-FX.899, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and… | Sedecal SA | 06/10/2025Open, Classified |
| Z-0244-2026 Class II | Model Number 40KWFX, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and… | Sedecal SA | 06/10/2025Open, Classified |
| Z-0243-2026 Class II | MobileDiagnost wDR 2.2; Model Number REF 9890-010-89522, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and… | Sedecal SA | 06/10/2025Open, Classified |