Camera, Scintillation (Gamma)
FDA product code IYX · Class I (low risk) · 21 CFR 892.1100 · Radiology
130510(k) clearances
0PMA approvals
3recalls
Manufacturers
- General Electric Co. 15
- Siemens Gammasonics, Inc. 11
- Adac Laboratories 6
- Toshiba Medical Systems 5
- Elscint, Inc. 5
- Medtronic Vascular 5
- Union Carbide Corp. 4
- Medx, Inc. 4
- Philips Medical Systems (Cleveland) Inc 3
- Technicare Corp. 3
- Dilon Technologies, Inc. 3
- Sopha Medical Systems, Inc. 3
- Digirad Corp. 3
- General Equipment For Medical Imaging, S.A. 2
- GE Medical Systems, LLC 2
- Engineering Dynamics Corp. 2
- Med-Tron Products, Inc. 2
- General Equipment For Medical Imaging (Oncovision- 2
- Gvi Technology Partners 2
- Computer Design & Applications, Inc. 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K230221 | QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy)IYX · Traditional | Versant Medical Physics and Radiation Safety | 08/28/2023SE |
| K212587 | 3D-RD-SIYX · Traditional | Radiopharmaceutical Imaging and Dosimetry, LLC | 02/22/2023SE |
| K163687 | Olinda ExmIYX · Traditional | Hermes Medical Solutions AB | 07/19/2017SE |
| K160933 | Discovery NM 750b BopsyIYX · Traditional | GE Healthcare | 11/18/2016SE |
| K162052 | Sentinella 102, Sentinella 102 HorusIYX · Special | General Equipment For Medical Imaging (Oncovision- | 08/18/2016SE |
| K143156 | Sentinella 102; Sentinella 102 HorusIYX · Traditional | General Equipment For Medical Imaging (Oncovision- | 11/18/2014SE |
| K123408 | Ergo Imaging SystemIYX · Traditional | Digirad Corp. | 01/15/2013SE |
| K111791 | Lumagem Molecular Breast Imaging SystemIYX · Traditional | Gamma Medica-Ideas Incorporated | 09/23/2011SE |
| K110384 | Dilon 6800 Acella (Acella)IYX · Traditional | Dilon Technologies, Inc. | 05/03/2011SE |
| K110601 | Sentinella 102IYX · Traditional | General Equipment For Medical Imaging, S.A. | 03/18/2011SE |
| K102231 | Discovery NM 750BIYX · Traditional | Ge Medical Systems Israel, Functional Imaging | 11/03/2010SE |
| K101391 | SCANDIA-45 Gamma Camera SystemIYX · Traditional | Scandia Corporation | 08/04/2010SE |
| K100838 | Ergo Imaging SystemIYX · Special | Digirad Corp. | 04/23/2010SE |
| K093706 | Proxiscan Model 101IYX · Traditional | Hybridyne Imaging Technologies, Inc. | 04/02/2010SE |
| K082588 | Gammaloc System, Model 03-00001IYX · Traditional | Dilon Technologies, LLC | 12/11/2009SE |
| K092471 | Model Sentinella 102IYX · Traditional | General Equipment For Medical Imaging, S.A. | 10/02/2009SE |
| K081757 | Verista Imaging Isocam II Gamma CameraIYX · Special | Verista Imaging, Inc. | 08/15/2008SE |
| K081829 | CapimageIYX · Traditional | Danish Diagnostic Development A/S | 07/11/2008SE |
| K073456 | T-Quest SystemIYX · Traditional | Medx, Inc. | 12/20/2007SE |
| K071195 | KHBS (Krishnamurthy Hepato-Biliary Software), Model Version 1.5IYX · Traditional | Ani-Kal Ii, LLC | 06/20/2007SE |
| K062141 | Mammopad Radiolucent CushionIYX · Traditional | Biolucent, Inc. | 09/13/2006SE |
| K052473 | CX 250 C Plus with Gammaxp Software, Model 0121 0000IYX · Traditional | Inter Medical Medizintechnik GmbH | 10/28/2005SE |
| K051402 | Onepass Nuclear Medicine Imaging SystemIYX · Special | Gvi Technology Partners | 06/13/2005SE |
| K033960 | Olinda/ExmIYX · Traditional | Vanderbilt University | 06/15/2004SE |
| K040587 | Mini Gamma Camera, Model MGC-500IYX · Traditional | Acrorad Co., Ltd. | 05/14/2004SE |
| K023373 | Onepass Nuclear Imaging System, Model 70-500101IYX · Traditional | Gvi Technology Partners | 01/03/2003SE |
| K022342 | Ez-Scope an, Ez-Scope LightIYX · Traditional | Anzai Medical Co., Ltd. | 10/09/2002SE |
| K020643 | Ez-Scope an & Ez-Scope an LiteIYX · Traditional | Health Policy Resorters Group, LLC | 05/28/2002SE |
| K003775 | Portable Breast Compression DeviceIYX · Traditional | Pem Technologies | 01/12/2001SE |
| K993813 | Lumagem Scintillation CameraIYX · Traditional | Gamma Medica | 01/18/2000SE |
| K984466 | Dilon 2000, Model 2000-6X8 and Dilon 2000, Model 2000-5X5IYX · Traditional | Dilon Technologies, Inc. | 03/16/1999SE |
| K961104 | Notebook ImagerIYX · Traditional | Digirad Corp. | 05/28/1997SE |
| K945792 | IM512PIYX · Traditional | Globus Industries | 05/24/1995SE |
| K943602 | DI-2000IYX · Traditional | Miles Inc., Agfa Division | 05/12/1995SE |
| K935273 | Vision FX 40 & 80 Series Gamma CameraIYX · Traditional | Summit Nuclear | 04/18/1994SE |
| K932701 | Cedars-Sinai Quantitive Thallium 201 AnalysisIYX · Traditional | Nuccardiac Software, Inc. | 03/29/1994SE |
| K934766 | Carbon Fiber PalletIYX · Traditional | Siemens Gammasonics, Inc. | 02/18/1994SE |
| K932673 | Apex SPX CardialIYX · Traditional | Elscint, Inc. | 02/18/1994SE |
| K933513 | R &D Batteries, Inc. Part # 5015, 5192, 5482IYX · Traditional | R & D Batteries, Inc. | 11/24/1993SE |
| K933256 | Fan Beam CollimatorIYX · Traditional | Siemens Gammasonics, Inc. | 10/29/1993SE |
| K932957 | Quantem (TM)IYX · Traditional | GE Medical Systems | 08/05/1993SE |
| K923180 | Specturn, Model TTK-128IYX · Traditional | Harpell Assoc., Inc. | 07/26/1993SE |
| K930283 | ThyrusIYX · Traditional | Adac Laboratories | 06/21/1993SE |
| K926550 | Unix-LinkIYX · Traditional | General Electric Co. | 03/18/1993SE |
| K926083 | Nuclear Patient Sanning Tables, Various TypesIYX · Traditional | Biodan Medical Systems, Ltd. | 02/12/1993SE |
| K924878 | New Detector OptionIYX · Traditional | Adac Laboratories | 01/15/1993SE |
| K924639 | New Detector for Transcam/Polaris S315IYX · Traditional | Adac Laboratories | 01/15/1993SE |
| K923356 | Medx Rotational Gantry SystemIYX · Traditional | Bfi- Medical Waste Systems | 09/21/1992SE |
| K921296 | Adac S315IYX · Traditional | Adac Laboratories | 05/28/1992SE |
| K910967 | NeurocamIYX · Traditional | GE Medical Systems | 07/03/1991SE |
| K905074 | Microdelta, TC-99M-MAG3 Renal Processing ProgramIYX · Traditional | Siemens Gammasonics, Inc. | 06/21/1991SE |
| K911346 | Sophycamera DSX BodytrakIYX · Traditional | Sopha Medical Systems, Inc. | 04/18/1991SE |
| K905412 | Es/Ultra Display and Processing StationIYX · Traditional | Toshiba America Medical Systems, In.C | 03/25/1991SE |
| K903469 | Gamma 600 Nuclear Medicine ComputerIYX · Traditional | Strichman Medical Equipment, Inc. | 02/04/1991SE |
| K905827 | Full View Omega TableIYX · Traditional | Med-Tron Products, Inc. | 01/28/1991SE |
| K904174 | Starcam 4000IYX · Traditional | General Electric Co. | 01/04/1991SE |
| K904050 | Model DH-1000 Single Detec./Dual Detec Nucl CameraIYX · Traditional | Philips Medical Systems (Cleveland), Inc. | 12/05/1990SE |
| K903030 | Sophycamera DSM 315IYX · Traditional | Provino | 10/29/1990SE |
| K903988 | Panoramic Omega Imaging TableIYX · Traditional | Med-Tron Products, Inc. | 10/23/1990SE |
| K900773 | Nuclear MaxIYX · Traditional | Scientific Imaging, Inc. | 05/23/1990SE |
| K900689 | Modified Adac Nuclear Medicine Gamma CameraIYX · Traditional | Adac Laboratories | 04/19/1990SE |
| K894931 | Sophycamera DSX RectangularIYX · Traditional | Sopha Medical Systems, Inc. | 10/27/1989SE |
| K893379 | Xenos MobilecamIYX · Traditional | Xenos Medical Systems, Inc. | 08/11/1989SE |
| K885054 | System Seventy SevenIYX · Traditional | Scinticor, Inc. | 04/19/1989SE |
| K884675 | Apex 609R Anger CameraIYX · Traditional | Elscint, Inc. | 04/17/1989SE |
| K884674 | Apex 415 Anger CameraIYX · Traditional | Elscint, Inc. | 04/17/1989SE |
| K884672 | Apex 115 Nuclear Medicine ProcessorIYX · Traditional | Elscint, Inc. | 04/17/1989SE |
| K884673 | Apex 215M Mobile Anger CameraIYX · Traditional | Elscint, Inc. | 04/14/1989SE |
| K884661 | D-Scope IIIIYX · Traditional | Medx, Inc. | 04/12/1989SE |
| K885242 | Microdelta IIIYX · Traditional | Siemens Gammasonics, Inc. | 03/30/1989SE |
| K880878 | CX250 Mobile Gamma Camera & DCS ConsoleIYX · Traditional | Philips Medical Systems (Cleveland), Inc. | 09/01/1988SE |
| K881013 | Multipurpose Digital Gammacamera, GCA-602AIYX · Traditional | Toshiba Medical Systems | 08/29/1988SE |
| K882312 | Model 3000 Nuclear CameraIYX · Traditional | Ohio Imaging, Inc. | 07/14/1988SE |
| K875198 | Digital Nuclear Imaging SystemIYX · Traditional | Medasys, Inc. | 07/01/1988SE |
| K872297 | DS-7 Nuclear Medicine Gamma CameraIYX · Traditional | Sopha Medical Systems, Inc. | 08/12/1987SE |
| K872127 | D-Scope II and D-Scope IicIYX · Traditional | Medx, Inc. | 06/18/1987SE |
| K871175 | Jumbo Digital Gammacamera, GCA-901AIYX · Traditional | Toshiba Medical Systems | 03/31/1987SE |
| K870818 | BodyscanIYX · Traditional | Siemens Gammasonics, Inc. | 03/16/1987SE |
| K870703 | Skan D-ScopeIYX · Traditional | Medx, Inc. | 02/26/1987SE |
| K861637 | Weighted Acquisition ModuleIYX · Traditional | Siemens Gammasonics, Inc. | 06/10/1986SE |
| K852648 | Starport Model H3300AAIYX · Traditional | General Electric Co. | 01/30/1986SE |
| K853482 | Ace Computer SystemIYX · Traditional | Cardiac Medical Systems Corp. | 01/01/1986SE |
| K853470 | Jumbo Digital Gammacamera GCA-90B Wi & W2IYX · Traditional | Toshiba Medical Systems | 11/19/1985SE |
| K852089 | Saturn Nuclear Medicine Computer SystemIYX · Traditional | Technicare Corp. | 07/18/1985SE |
| K851644 | Spectrum 150 DTIYX · Traditional | Raytheon Medical Systems | 05/21/1985SE |
| K850463 | Basicam Counter Balance CameraIYX · Traditional | Siemens Gammasonics, Inc. | 04/10/1985SE |
| K850397 | Orbitor II Counter Balance CameraIYX · Traditional | Siemens Gammasonics, Inc. | 03/26/1985SE |
| K844218 | Tomographic GantryIYX · Traditional | General Electric Co. | 03/01/1985SE |
| K843716 | Nuclear 700 Medicine Mechanical Posit-IYX · Traditional | Technicare Corp. | 12/17/1984SE |
| K843558 | Deltanode, Mega Delta, Delta Link-IYX · Traditional | Computer Design & Applications, Inc. | 11/13/1984SE |
| K843288 | Ketronic Medax - NIYX · Traditional | Ketronic, Inc. | 11/08/1984SE |
| K841964 | Micro Delta & CeltaproIYX · Traditional | Computer Design & Applications, Inc. | 08/21/1984SE |
| K841906 | Maxicamera 400 AcIYX · Traditional | General Electric Co. | 07/06/1984SE |
| K840052 | Digital Processing SystemIYX · Traditional | Adac Laboratories | 03/22/1984SE |
| K833821 | Interad 520IYX · Traditional | Interad Systems, Inc. | 01/13/1984SE |
| K833811 | Cardiac CameraIYX · Traditional | Siemens Gammasonics, Inc. | 12/27/1983SE |
| K832505 | Image Processing Sys A3IYX · Traditional | Metronic, Inc. | 09/12/1983SE |
| K820244 | Add'L Terminal Support for Star BasicIYX · Traditional | General Electric Co. | 03/02/1982SE |
| K813073 | Omega 500 Rectangular Field Camera W/ScIYX · Traditional | Technicare Corp. | 12/08/1981SE |
| K811629 | Dyna- MoIYX · Traditional | Philips Medical Systems (Cleveland), Inc. | 09/08/1981SE |
| K811715 | Rota CameraIYX · Traditional | Siemens Gammasonics, Inc. | 07/20/1981SE |
| K811676 | Maxi Camera/DIYX · Traditional | General Electric Co. | 07/02/1981SE |
| K811187 | Medtronic A2 Clinical Imaging SystemIYX · Traditional | Medtronic Vascular | 05/27/1981SE |
| K810974 | Gamma CameraIYX · Traditional | Siemens Gammasonics, Inc. | 05/13/1981SE |
| K802475 | A2 Image Processing SystemIYX · Traditional | Medtronic Vascular | 11/26/1980SE |
| K801654 | Maxi Camera 61IYX · Traditional | General Electric Co. | 08/20/1980SE |
| K801653 | Maxi Camera 37IYX · Traditional | General Electric Co. | 08/20/1980SE |
| K801368 | A2 Image Processing SystemIYX · Traditional | Medtronic Vascular | 07/21/1980SE |
| K791682 | Cleon 720 Large Field Gamma CameraIYX · Traditional | Union Carbide Corp. | 12/13/1979SE |
| K790466 | U-MatIYX · Traditional | Engineering Dynamics Corp. | 03/28/1979SE |
| K790499 | Multiple Pinhole Tomographic CollimoterIYX · Traditional | Engineering Dynamics Corp. | 03/26/1979SE |
| K790463 | Modu-Set CollimotorIYX · Traditional | Medtronic Vascular | 03/26/1979SE |
| K790081 | Camera, Cleon 720 Large Field GammaIYX · Traditional | Union Carbide Corp. | 01/26/1979SE |
| K782029 | Maxi Camera 400TIYX · Traditional | General Electric Co. | 12/22/1978SE |
| K782047 | Processing System, A2 ImageIYX · Traditional | Medtronic Vascular | 12/20/1978SE |
| K781739 | Camera, GCA-10A, Low EnergyIYX · Traditional | Toshiba Medical Systems | 11/27/1978SE |
| K781673 | Maxi-Camera 535IYX · Traditional | General Electric Co. | 10/17/1978SE |
| K780969 | Gamma CameraIYX · Traditional | Machlett Laboratories, Inc. | 06/27/1978SE |
| K780971 | Clinical Acquisition ModuleIYX · Traditional | Analytical Development Assoc. Corp. | 06/22/1978SE |
| K780855 | Gamma CameraIYX · Traditional | G.D. Searle and Co. | 06/02/1978SE |
| K780491 | Data CameraIYX · Traditional | General Electric Co. | 04/18/1978SE |
| K780165 | Processor, Video Image VIP-550IYX · Traditional | Ohio Nuclear, Inc. | 03/02/1978SE |
| K780155 | Dual Channel Pulse Height AnalyzerIYX · Traditional | Iso Graphics, Inc. | 03/02/1978SE |
| K780060 | Camera, GammaIYX · Traditional | Ackerman-Schmehl Industries, Inc. | 01/26/1978SE |
| K771599 | Gamma Cameras -GXA-301 & GCA-402IYX · Traditional | Toshiba Medical Systems | 09/20/1977SE |
| K770954 | Univue IIYX · Traditional | Union Carbide Corp. | 07/01/1977SE |
| K770753 | Porta Camera IicIYX · Traditional | General Electric Co. | 05/10/1977SE |
| K770531 | Unicam IIYX · Traditional | Union Carbide Corp. | 04/05/1977SE |
| K770343 | Maxicamera IIIYX · Traditional | General Electric Co. | 02/28/1977SE |
| K761159 | Portacamera 11-BIYX · Traditional | General Electric Co. | 12/06/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1046-2026 Class II | SMV BodyTrack, System, Tomography, Computed, EmissionGE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed… | GE Medical Systems Israel, Functional Imaging | 12/10/2025Open, Classified |
| Z-1044-2026 Class II | SMV DSX New Line, System, Tomography, Computed, EmissionGE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed… | GE Medical Systems Israel, Functional Imaging | 12/10/2025Open, Classified |
| Z-2758-2016 Class II | e.cam and Symbia E gamma camera systems with patient beds To detect or image the…"We have received reports of patients hair being caught in the e.cam and Symbia E patient bed up/down drive.… | Siemens Medical Solutions USA, Inc. | 08/05/2016Terminated |