System, Image Processing, Radiological
FDA product code LLZ · Class II (moderate risk) · 21 CFR 892.2050 · Radiology
2,287510(k) clearances
0PMA approvals
521recalls
Manufacturers
- Siemens Medical Solutions USA, Inc. 74
- Totoku Electric Co., Ltd. 40
- Barco N.V. 37
- Eizo Nanao Corporation 34
- Vital Images, Inc. 34
- Ewoosoft Co., Ltd. 29
- GE Healthcare, LLC 23
- Fujifilm Medical System U.S.A., Inc. 19
- GE Medical Systems, LLC 19
- Pie Medical Imaging BV 18
- Siemens AG Medical Solutions 17
- Philips Medical Systems Nederland B.V. 17
- Barcoview 17
- Materialise NV 16
- Philips Medical Systems North America, Inc. 16
- Brainlab AG 14
- Barco NV Barcoview 14
- Philips Medical Systems 14
- Mim Software, Inc. 14
- Adac Laboratories 14
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262060 | 3D-RD-SLLZ · Traditional | Radiopharmaceutical Imaging & Dosimetry, LLC | 09/04/2026SE |
| K261500 | KBA3D (v2.4.0)LLZ · Traditional | S.M.A.I.O | 08/17/2026SE |
| K262449 | AdvaViewLLZ · Special | Advahealth Solutions, LLC | 08/14/2026SE |
| K261916 | NeuroQuant PETLLZ · Traditional | Cortechs Labs, Inc. | 08/12/2026SE |
| K260936 | RadioViewAILLZ · Traditional | Neurocareai, Inc. (Dba Savelife.Ai) | 07/31/2026SE |
| K260588 | Cleerly LABSLLZ · Traditional | Cleerly, Inc. | 07/29/2026SE |
| K262462 | TheraSphere 360 Y-90 Management PlatformLLZ · Special | Boston Scientific Corporation | 07/24/2026SE |
| K262143 | ImageGrid StreamVueLLZ · Traditional | Candelis, Inc. | 07/23/2026SE |
| K260500 | ResolutionMDLLZ · Traditional | ResolutionMD, Inc. | 07/21/2026SE |
| K262120 | Avara ViewerLLZ · Traditional | Avara Software | 07/10/2026SE |
| K253899 | 3D-AnywhereLLZ · Traditional | Provect.AI | 07/09/2026SE |
| K261465 | Indira Cloud ViewerLLZ · Traditional | Indigo Technologies | 07/06/2026SE |
| K260576 | MeVis AVM ContourLLZ · Traditional | MeVis Medical Solutions AG | 06/30/2026SE |
| K260231 | MiPACS V5 (1.0.0)LLZ · Traditional | Apryse Software Corp | 06/25/2026SE |
| K253421 | Perfusion Measurement Platform v1LLZ · Traditional | Quantified Imaging Limited | 06/22/2026SE |
| K261352 | 2D Hip Planning SoftwareLLZ · Traditional | One Ortho | 06/08/2026SE |
| K260116 | CustoMED ViewerLLZ · Traditional | CustoMED , Ltd. | 06/03/2026SE |
| K254265 | Helion Viewer SuiteLLZ · Traditional | Videomed Srl ( a Baxter Healthcare Corp company) | 05/27/2026SE |
| K253831 | CMN Capillary Function with Virtual Expert for MRI, CT and CBCTLLZ · Traditional | Cercare Medical A/S | 05/18/2026SE |
| K254013 | SubtleHD-PET (1.x)LLZ · Traditional | Subtle Medical, Inc. | 05/14/2026SE |
| K260321 | HipGuide (V 1.0.0.0)LLZ · Traditional | Orthopedic Driven Imaging, LLC | 05/08/2026SE |
| K260716 | NeowiseLLZ · Traditional | Cefla S.C. | 05/04/2026SE |
| K260009 | LungPoint Virtual Bronchoscopic Navigation (VBN) SoftwareLLZ · Traditional | Broncus Medical, Inc. | 04/24/2026SE |
| K254237 | Cci Pacs Viewer (PACS-US-001)LLZ · Traditional | CliniComp, Intl. | 04/23/2026SE |
| K253029 | RW-1LLZ · Traditional | Mediott, Inc. | 03/31/2026SE |
| K253950 | Avatar Medical VisionLLZ · Traditional | Avatar Medical | 03/30/2026SE |
| K252195 | ARTICOR plannerLLZ · Traditional | Artiness S.R.L | 03/27/2026SE |
| K260479 | TheraSphere 360 Y-90 Management PlatformLLZ · Special | Boston Scientific Corporation | 03/13/2026SE |
| K253111 | Aeka ImagingLLZ · Traditional | Good Methods Global, Inc. | 03/13/2026SE |
| K251964 | Mimics Thoracic PlannerLLZ · Traditional | Materialise NV | 03/12/2026SE |
| K253486 | SKIA-Head (Model: SKIA-ST00)LLZ · Traditional | Skia, Inc. | 02/23/2026SE |
| K260205 | AS Software Version AseraLLZ · Special | AS Software, LLC | 02/19/2026SE |
| K253927 | LiveMedica Enterprise PACSLLZ · Traditional | Live Medica, LLC | 02/06/2026SE |
| K251577 | Laia XRLLZ · Traditional | Augmented Reality Software S.L. | 02/06/2026SE |
| K253784 | 3DICOM MD CloudLLZ · Traditional | Singular Health Pty, Ltd. | 01/08/2026SE |
| K253639 | ViewLLZ · Traditional | GE Healthcare | 01/08/2026SE |
| K253008 | maiLinkLLZ · Traditional | Maihub Corp. | 01/05/2026SE |
| K251883 | MIM LesionID ProLLZ · Traditional | Mim Software, Inc. | 12/11/2025SE |
| K251880 | Archy Dental ImagingLLZ · Traditional | Archy Dental, Inc. | 11/21/2025SE |
| K253495 | syngo.MR Applications (VB80)LLZ · Traditional | Siemens Healthineers AG | 11/20/2025SE |
| K251410 | VXvueLLZ · Traditional | Vieworks Co., Ltd. | 11/04/2025SE |
| K251532 | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)LLZ · Traditional | Mighty Oak Medical | 11/03/2025SE |
| K252547 | TheraSphere 360 Y-90 Management PlatformLLZ · Traditional | Boston Scientific Corporation | 10/28/2025SE |
| K251030 | Sirona Advanced Imaging SuiteLLZ · Traditional | Sirona Medical | 10/22/2025SE |
| K252476 | Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart…LLZ · Special | Brainlab AG | 10/16/2025SE |
| K252199 | AGFA HealthCare Enterprise ImagingLLZ · Traditional | Agfa Healthcare N.V. | 10/15/2025SE |
| K251363 | ProKnow DSLLZ · Traditional | Elekta Solutions AB | 10/08/2025SE |
| K250039 | HpacsLLZ · Traditional | Healthhub | 10/03/2025SE |
| K251215 | Philips IntelliSpace CardiovascularLLZ · Traditional | Philips Medical Systems Nederland B.V. | 10/02/2025SE |
| K250045 | uWS-Angio ProLLZ · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 09/24/2025SE |
| K250040 | uWS-AngioLLZ · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 09/12/2025SE |
| K242314 | Minimally Invasive Prostate Surgery Navigation System(Model:AmaKris SR1-A-2)LLZ · Traditional | Augment Intelligent Medical System (China) Co.… | 09/11/2025SE |
| K252608 | AI-Rad Companion Prostate MRLLZ · Traditional | Siemens Healthcare GmbH | 09/09/2025SE |
| K251168 | Image SuiteLLZ · Traditional | Carestream Health, Inc. | 09/04/2025SE |
| K250290 | SurgiTwinLLZ · Traditional | Twinsight | 08/29/2025SE |
| K252526 | Rapid DeltaFuseLLZ · Traditional | Ischemaview, Inc. | 08/26/2025SE |
| K243680 | Neurovascular Insight V1.0LLZ · Traditional | Olea Medical S.A.S. | 08/25/2025SE |
| K232456 | RW-1LLZ · Traditional | Mediott, Inc. | 08/11/2025SE |
| K250664 | Navigo Workstation 2.3 (FPRMC00039)LLZ · Traditional | UC-CARE , Ltd. | 08/07/2025SE |
| K251038 | Digital Radiographic Imaging Acquisition Software - DR (RiasDR)LLZ · Traditional | Shen Zhen Cambridge-Hit Co., Ltd. | 08/06/2025SE |
| K244016 | iPETcertum (v1.0)LLZ · Traditional | Claritas Healthtech Pte, Ltd. | 08/05/2025SE |
| K250716 | Image OneLLZ · Traditional | Infomed Software, S.L. | 07/23/2025SE |
| K243681 | Neuro Insight V1.0LLZ · Traditional | Olea Medical S.A.S. | 07/23/2025SE |
| K250686 | GyriCalc (Version 1.0.0)LLZ · Traditional | Neurospectrum Insights Corp. | 07/22/2025SE |
| K250181 | AV ViewerLLZ · Traditional | Philips Medical Systems Nederland B.V. | 07/15/2025SE |
| K250120 | GechoLLZ · Traditional | Narnar, LLC | 07/14/2025SE |
| K251863 | CustomSurg OrthoPlannerLLZ · Traditional | Customsurg AG | 07/07/2025SE |
| K243666 | uOmniscanLLZ · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 06/17/2025SE |
| K244012 | Mosaic (V1.0.1)LLZ · Traditional | Navier Medical | 06/16/2025SE |
| K250800 | UroNav 4LLZ · Traditional | Philips DS North America, LLC | 06/05/2025SE |
| K243703 | TechLiveLLZ · Traditional | DeepHealth, Inc. | 06/05/2025SE |
| K251109 | SMARTDentLLZ · Traditional | Ray Co., Ltd. | 05/21/2025SE |
| K243632 | uWS-Angio BasicLLZ · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 05/12/2025SE |
| K243069 | Lumys (V1)LLZ · Traditional | Intradys | 05/02/2025SE |
| K243697 | MySpine WebPlannerLLZ · Traditional | Medacta International S.A. | 04/23/2025SE |
| K243651 | VersaViewerLLZ · Traditional | GE Medical Systems SCS | 04/21/2025SE |
| K242647 | MySegmenter (v2.0.0)LLZ · Traditional | Mysegmenter Technologies, Inc. | 04/16/2025SE |
| K250301 | Merge Universal Viewer (MUV)LLZ · Traditional | Merge Healthcare Incorporated | 04/14/2025SE |
| K242552 | Horos MobileLLZ · Traditional | Icat Solutions, Ltd. | 04/08/2025SE |
| K243292 | brAIn Shoulder PositioningLLZ · Traditional | Avatar Medical | 03/20/2025SE |
| K242161 | Radlink GPS Pro ImagingLLZ · Traditional | Radlink, Inc. | 03/18/2025SE |
| K241975 | Serv Medical CDSSLLZ · Traditional | Serv Medical Pte., Ltd. | 03/17/2025SE |
| K241765 | PLANET Onco Dose (3.2)LLZ · Traditional | Dosisoft SA | 03/14/2025SE |
| K241546 | aiCockpit AI ViewerLLZ · Traditional | Fovia, Inc. | 02/26/2025SE |
| K250348 | JLK-AILinkLLZ · Traditional | JLK, Inc. | 02/25/2025SE |
| K242838 | QuickRadLLZ · Traditional | Aikenist Technologies Pvt, Ltd. | 02/21/2025SE |
| K242240 | CaRi-PlaqueLLZ · Traditional | Caristo Diagnostics , Ltd. | 02/20/2025SE |
| K241425 | AspenViewLLZ · Traditional | Aspen Imaging Healthcare, Inc. | 02/12/2025SE |
| K243333 | rTOPLLZ · Traditional | Roclub GmbH | 02/04/2025SE |
| K241694 | ZeTTA PACSLLZ · Traditional | Tae Young Soft Co., Ltd. | 01/31/2025SE |
| K241819 | CephNinjaLLZ · Traditional | Cyncronus, LLC | 01/23/2025SE |
| K242205 | SpectoMed (v1.0)LLZ · Traditional | Specto Medical | 01/14/2025SE |
| K241808 | ApolloHipX (THR.SS.0001)LLZ · Traditional | Corin U.S.A. Limited | 01/07/2025SE |
| K242123 | Brainomix 360 e-CTALLZ · Traditional | Brainomix Limited | 01/06/2025SE |
| K241350 | Clarify DLLLZ · Traditional | Ge Medical Systems Israel, Functional Imaging | 01/03/2025SE |
| K242599 | aprevo® Digital PlanningLLZ · Traditional | Carlsmed, Inc. | 12/20/2024SE |
| K242362 | Lightning ViewerLLZ · Traditional | Nexsys Electronics Inc. Dba Medweb | 12/20/2024SE |
| K241989 | Cercare Medical Neurosuite (CMN) Capillary Function with Virtual ExpertLLZ · Traditional | Cercare Medical A/S | 12/06/2024SE |
| K240926 | PeekMed webLLZ · Traditional | Peek Health, S.A. | 12/06/2024SE |
| K243447 | Rapid Surgical Plan (RSP-SW-001)LLZ · Traditional | Navbit Pty, Ltd. | 12/05/2024SE |
| K242810 | RadUnity (Version 1.0.0)LLZ · Traditional | Radunity Corp. | 11/26/2024SE |
| K241495 | Jazz ClassicLLZ · Traditional | Jazz Imaging | 11/21/2024SE |
| K242329 | CT Collaboration LiveLLZ · Traditional | Philips Healthcare (Suzhou) Co., Ltd. | 11/18/2024SE |
| K242062 | 1CMR ProLLZ · Abbreviated | Mycardium AI Limited | 11/15/2024SE |
| K241981 | Change Healthcare Stratus Imaging PACSLLZ · Traditional | Change Healthcare Canada Company | 11/12/2024SE |
| K242709 | Jlk-PwiLLZ · Traditional | JLK, Inc. | 11/04/2024SE |
| K241223 | eRAD PACSLLZ · Traditional | Erad, Inc. | 10/31/2024SE |
| K242512 | ROCC ConsoleLLZ · Traditional | Philips Medical Systems Nederland B.V. | 10/24/2024SE |
| K243012 | MIM Symphony HDR FusionLLZ · Special | Mim Software, Inc. | 10/23/2024SE |
| K243209 | nordicMEDiVALLZ · Traditional | Nordicneurolab AS | 10/22/2024SE |
| K242556 | Jlk-CtpLLZ · Traditional | JLK, Inc. | 10/16/2024SE |
| K240385 | VintLLZ · Traditional | Mediimg Corporation | 10/15/2024SE |
| K241569 | syngo Application SoftwareLLZ · Traditional | Siemens Medical Solutions USA, Inc. | 10/11/2024SE |
| K240243 | EConsole2LLZ · Traditional | DRTECH Corporation | 09/23/2024SE |
| K241524 | Elucid PlaqueIQLLZ · Traditional | Elucid Bioimaging, Inc. | 09/12/2024SE |
| K233998 | TRAQinform IQLLZ · Traditional | Aiq Global, Inc. | 09/05/2024SE |
| K241302 | SonoSyncLLZ · Traditional | Samsung Medison Co., Ltd. | 08/23/2024SE |
| K240290 | AiMIFY (1.x)LLZ · Traditional | Subtle Medical, Inc. | 08/21/2024SE |
| K241094 | BullsaiLLZ · Traditional | Turing Medical Technologies, Inc. | 08/13/2024SE |
| K240724 | SynthVISION 1.0.0LLZ · Traditional | Synthesis Health Intelligence, Inc. | 08/08/2024SE |
| K233761 | Orthopaedic Surgery Planning Software (AIJOINT)LLZ · Traditional | Longwood Valley Medical , Ltd. | 08/05/2024SE |
| K241114 | EzDent-i / E2 / Prora View / Smart M Viewer (v3.5)LLZ · Special | Ewoosoft Co., Ltd. | 07/23/2024SE |
| K241879 | vRad ViewerLLZ · Special | Virtual Radiologic Corporation | 07/18/2024SE |
| K241121 | Micsi-RmtLLZ · Traditional | Microstructure Imaging, Inc. | 07/17/2024SE |
| K240705 | Vitrea Software Package, VSTP-002A V2.0LLZ · Traditional | Canon Medical Systems Corporation | 07/17/2024SE |
| K241300 | ViewPoint 6LLZ · Traditional | Ge Healthcare GmbH | 07/02/2024SE |
| K233908 | cNeuro cDATLLZ · Traditional | Combinostics OY | 07/01/2024SE |
| K241608 | nordicMEDiVALLZ · Traditional | Nordicneurolab AS | 06/28/2024SE |
| K233331 | MediOMxLLZ · Traditional | Pmx, Inc. | 06/17/2024SE |
| K240281 | Bone Suppression SoftwareLLZ · Traditional | Konica Minolta, Inc. | 05/31/2024SE |
| K223427 | Mimics Enlight CMFLLZ · Traditional | Materialise NV | 05/31/2024SE |
| K240294 | Syngo Carbon Enterprise Access (VA40A)LLZ · Traditional | Siemens Healthcare GmbH | 05/23/2024SE |
| K232759 | Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart…LLZ · Traditional | Brainlab AG | 05/21/2024SE |
| K233620 | MIM - Centiloid ScalingLLZ · Traditional | Mim Software, Inc. | 05/20/2024SE |
| K232862 | MIM Monte Carlo DosimetryLLZ · Traditional | Mim Software, Inc. | 05/13/2024SE |
| K232976 | VUZE SystemLLZ · Traditional | Vuze Medical , Ltd. | 05/09/2024SE |
| K232514 | MIM Dose AnalysisLLZ · Traditional | Mim Software, Inc. | 05/06/2024SE |
| K233699 | SubtleREFORMAT (1.x)LLZ · Traditional | Subtle Medical, Inc. | 04/29/2024SE |
| K240839 | OpenRad CloudLLZ · Traditional | Openrad Services Uk, Ltd. | 04/24/2024SE |
| K240822 | Image Management V15LLZ · Traditional | Philips Medical Systems Technologies | 04/24/2024SE |
| K233582 | RapidLLZ · Traditional | Ischemaview, Inc. | 04/22/2024SE |
| K232641 | Neorad Pacs (Neorad Pacs)LLZ · Traditional | Everrtech Software Pvt, Ltd. | 04/10/2024SE |
| K232891 | Carpl (Carpl)LLZ · Traditional | Carpl Ai, Inc. | 03/27/2024SE |
| K240620 | Cube NavigatorLLZ · Traditional | Medical Templates AG | 03/25/2024SE |
| K233660 | nCommand Lite SystemLLZ · Traditional | Ionic Health | 03/18/2024SE |
| K233599 | X-Clever (ASHK100G)LLZ · Traditional | Lg Electronics.Inc | 03/18/2024SE |
| K233930 | MRCP+ version 2 (MRCP+ v2)LLZ · Traditional | Perspectum | 03/13/2024SE |
| K233572 | AutofuseLLZ · Traditional | Pymedix | 03/06/2024SE |
| K233217 | Mimics Cardiac PlannerLLZ · Traditional | Materialise NV | 02/12/2024SE |
| K231662 | Aid-ULLZ · Traditional | Iaid | 02/08/2024SE |
| K232339 | Augmented Reality ApplicationLLZ · Traditional | Sira Medical, Inc. | 02/01/2024SE |
| K232007 | CAAS MR SolutionsLLZ · Traditional | Pie Medical Imaging BV | 02/01/2024SE |
| K231396 | CEPHX- Cephalometric Analysis SoftwareLLZ · Traditional | Orca Dental AI , Ltd. | 01/31/2024SE |
| K233714 | BreViewLLZ · Traditional | GE Medical Systems SCS | 01/25/2024SE |
| K231607 | Axial3D Cloud Segmentation ServiceLLZ · Special | Axial Medical Printing Limited | 01/24/2024SE |
| K233226 | FlexView Diagnostic (v1.1.20)LLZ · Traditional | Radical Imaging, LLC | 01/17/2024SE |
| K232589 | Horos MDLLZ · Traditional | Icat Solutions, Ltd. | 01/03/2024SE |
| K232744 | syngo Virtual Cockpit (VB10A)LLZ · Traditional | Siemens Healthcare GmbH | 12/21/2023SE |
| K233176 | uOmnispace.MILLZ · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 12/20/2023SE |
| K230955 | syngo Application SoftwareLLZ · Traditional | Siemens Medical Solutions USA, Inc. | 12/20/2023SE |
| K231570 | StrokeViewer PerfusionLLZ · Traditional | Nico-Lab B.V. | 12/14/2023SE |
| K233634 | TeleScanLLZ · Traditional | Bb Imaging | 12/12/2023SE |
| K231898 | DTX Studio Clinic (4.0)LLZ · Traditional | Nobel Biocare AB | 12/08/2023SE |
| K232661 | Myocardial Strain Software ApplicationLLZ · Traditional | Circle Cardiovascular Imaging | 12/07/2023SE |
| K231498 | TraumaCad NeoLLZ · Traditional | Brainlab , Ltd. | 11/20/2023SE |
| K230856 | BrainSpec Core SoftwareLLZ · Traditional | Brainspec, Inc. | 11/14/2023SE |
| K230854 | SwiftMRLLZ · Traditional | Airs Medical, Inc. | 10/27/2023SE |
| K232086 | spineEOSLLZ · Traditional | Eos Imaging | 10/24/2023SE |
| K223909 | R2GATE Lite TMLLZ · Traditional | Megagen Implant Co., Ltd. | 10/20/2023SE |
| K231225 | EConsole1LLZ · Traditional | DRTECH Corporation | 10/18/2023SE |
| K230249 | IkshanaLLZ · Traditional | Immersivetouch | 10/16/2023SE |
| K231642 | Veuron-Brain-pAb3LLZ · Traditional | Heuron Co., Ltd. | 10/13/2023SE |
| K230252 | OFIX MIS AppLLZ · Traditional | Orthofix US, LLC | 09/26/2023SE |
| K223659 | JazzLLZ · Traditional | Ai Medical AG | 09/22/2023SE |
| K231385 | Rology Teleradiology Platform (v.1.22.1103)LLZ · Traditional | Rology, Inc. | 09/20/2023SE |
| K232189 | OrionXRLLZ · Traditional | Hoth Intelligence, Inc. | 09/14/2023SE |
| K231353 | AccuCTP ProLLZ · Special | ArteryFlow Technology Co., Ltd. | 09/14/2023SE |
| K220034 | NEUROShieldLLZ · Traditional | In-Med Prognostics L3c | 09/14/2023SE |
| K231047 | UniSyn Molecular Imaging (6-3-1)LLZ · Traditional | Convergent Imaging Solutions | 09/01/2023SE |
| K231656 | Brainomix 360 e-MRILLZ · Traditional | Brainomix Limited | 08/30/2023SE |
| K223180 | AIRAscoreLLZ · Traditional | Airamed GmbH | 08/25/2023SE |
| K231503 | CUPTIMIZE AdvancedLLZ · Traditional | DePuy Orthopaedics, Inc. | 08/22/2023SE |
| K223660 | SaintViewLLZ · Traditional | Inviz Corporation | 08/14/2023SE |
| K232100 | Efai Pacs Picture Archiving and Communication System ProLLZ · Special | Ever Fortune.Ai, Co., Ltd. | 08/08/2023SE |
| K230540 | Patient Specific Planning Solution 3D Bone ModelsLLZ · Traditional | Biomet Manufacturing Corp | 07/25/2023SE |
| K223322 | Argus Cognitive ReVISION SoftwareLLZ · Traditional | Argus Cognitive, Inc. | 07/24/2023SE |
| K222683 | Fibroid Mapping Reviewer Application (FMRA)LLZ · Traditional | Nesa Medtech Private Limited | 07/17/2023SE |
| K231041 | JiveX (Model Number / Release: 5.4)LLZ · Traditional | Visus Health IT GmbH | 07/14/2023SE |
| K230016 | Cercare Medical NeurosuiteLLZ · Traditional | Cercare Medical A/S | 07/14/2023SE |
| K223290 | CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02)LLZ · Traditional | Sentiar, Inc. | 07/14/2023SE |
| K231351 | Chondral QuantLLZ · Traditional | Siemens Medical Soultions USA, Inc. | 07/13/2023SE |
| K223125 | XR90 (XR90-SYS)LLZ · Traditional | Mediview Xr, Inc. | 07/13/2023SE |
| K213253 | Pixyl.NeuroLLZ · Traditional | Pixyl SA | 06/30/2023SE |
| K223048 | Medisystem PacsLLZ · Traditional | Medilab Manutencao E Sitemas Ltda | 06/23/2023SE |
| K223091 | CT Perfusion V1.0LLZ · Traditional | Olea Medical | 06/09/2023SE |
| K231360 | Ambra PACSLLZ · Special | Dicom Grid Dba Ambra Health | 06/07/2023SE |
| K223532 | Olea S.I.A. Neurovascular V1.0LLZ · Traditional | Olea Medical | 06/06/2023SE |
| K223555 | Brainomix 360 e-CTPLLZ · Traditional | Brainomix Limited | 06/01/2023SE |
| K223841 | KBA3DLLZ · Traditional | S.M.A.I.O | 05/30/2023SE |
| K222359 | Quicktome Software SuiteLLZ · Traditional | Omniscient Neurotechnology Pty Ltd (O8t) | 05/30/2023SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-3171-2026 | Core Services Hub V8, a set of backend services including Cross Enterprise (XE) and…Under certain conditions historical imaging data migrated from a legacy system may become incorrectly… | GE Healthcare | 07/31/2026Open, Classified |
| Z-3170-2026 | Workflow Core Services V8, intended to provide set of services for storage and retrieval…Under certain conditions historical imaging data migrated from a legacy system may become incorrectly… | GE Healthcare | 07/31/2026Open, Classified |
| Z-3169-2026 | Centricity PACS Server V7, intended for managing digital medical images and associated…Under certain conditions historical imaging data migrated from a legacy system may become incorrectly… | GE Healthcare | 07/31/2026Open, Classified |
| Z-3168-2026 | Centricity PACS V2, V3, V4, V6, V7, software product is intended for the storage…Under certain conditions historical imaging data migrated from a legacy system may become incorrectly… | GE Healthcare | 07/31/2026Open, Classified |
| Z-3167-2026 | Enterprise Archive V8, software product for receiving, archiving, and sending electronic…Under certain conditions historical imaging data migrated from a legacy system may become incorrectly… | GE Healthcare | 07/31/2026Open, Classified |
| Z-3166-2026 | Centricity Enterprise Archive V2, V3, and V4, software product for receiving, archiving…Under certain conditions historical imaging data migrated from a legacy system may become incorrectly… | GE Healthcare | 07/31/2026Open, Classified |
| Z-3030-2026 Class II | FUJIFILM Synapse PACS software v7.4.310; radiological image processing systemSoftware issue may cause the ruler measurement to be inaccurate. | FUJIFILM Healthcare Americas Corporation | 07/22/2026Open, Classified |
| Z-3004-2026 Class II | Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstationSoftware issue may cause measurements to be displayed inaccurately. | Merge Healthcare, Inc. | 07/22/2026Open, Classified |
| Z-2875-2026 Class II | Merge OrthoPACS, medical imaging diagnostic workstationMerge Healthcare has identified a potential issue that may cause thumbnails from a previously opened patient… | Merge Healthcare, Inc. | 06/30/2026Open, Classified |
| Z-2874-2026 Class II | Merge PACS, medical imaging diagnostic workstationMerge Healthcare has identified a potential issue that may cause thumbnails from a previously opened patient… | Merge Healthcare, Inc. | 06/30/2026Open, Classified |
| Z-2771-2026 Class II | Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001…Software anomaly occurs when a user adds one or more vials to the cart and subsequently returns to the… | Boston Scientific Corporation | 06/19/2026Open, Classified |
| Z-2553-2026 Class II | GE Healthcare AW Server 3.2 ext.6.5; Radiological Image Processing SystemGE HealthCare has become aware of a context synchronization issue in AW Server 3.2 ext. 6.5. When a user… | GE Medical Systems SCS | 05/08/2026Open, Classified |
| Z-1805-2026 Class II | Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device…Potential safety issue involving the Mean Aneurysm Flow Amplitude (MAFA) ratio of AneurysmFlow… | Philips Medical Systems Nederland B.V. | 03/19/2026Open, Classified |
| Z-1692-2026 Class II | Vue Motion V12. Product Number: 1017979.Potential that mis-ordered frames in Vue Motion during dynamic cine runs may cause images frames to display… | Philips Medical Systems Nederland B.V. | 03/05/2026Open, Classified |
| Z-1571-2026 Class II | Centricity Universal Viewer Software Versions 5.0 SP6 through UV 5.0 SP7.1, a device…There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer.… | GE Medical Systems, LLC | 01/30/2026Open, Classified |
| Z-1570-2026 Class II | Centricity Universal Viewer Software Versions 6.0 through 6.0 Sp10.4.1, a device that…There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer.… | GE Medical Systems, LLC | 01/30/2026Open, Classified |
| Z-1569-2026 Class II | Centricity Universal Viewer Software Versions 7.0 through 7.0 Sp2.0.1, a device that…There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer.… | GE Medical Systems, LLC | 01/30/2026Open, Classified |
| Z-1475-2026 Class II | GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers:…Under certain workflows, patient information shown in the viewer may not match the images displayed on… | GE Healthcare | 01/16/2026Open, Classified |
| Z-2068-2026 Class II | Mint Lesion; Software Versions: 3.4.0 up to 3.9.5.;If the connection between a mint Lesion workstation and the mint Lesion server is interrupted while… | Mint Medical GmbH | 01/07/2026Open, Classified |
| Z-1243-2026 Class II | Focalyx FusionSoftware device that is an accessory for image-guided interventional and diagnostic procedures involving… | Focalyx Technologies, LLC. | 12/23/2025Open, Classified |
| Z-0941-2026 Class II | Intelerad InteleShare software, with ProViewer componentSoftware intended to aid in diagnosing conditions, planning treatments, visualizing anatomical structures… | DICOM Grid, Inc. | 11/18/2025Open, Classified |
| Z-0935-2026 Class II | GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing systemGE HealthCare has become aware that the Patient History tab in ViewPoint 6 versions 6.15.3 and 6.15.4… | GE Healthcare GmbH | 11/03/2025Open, Classified |
| Z-0723-2026 Class II | IntelePACS - InteleConnect / TechPortalSoftware application that receives digital images and data to be communicated, processed, manipulated… | Intelerad Medical Systems Incorporated | 10/17/2025Open, Classified |
| Z-0325-2026 Class II | Surgical Planner, BrainSTORM, software version BST.9.3.0, orthopedic augmented realityA software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image… | Surgical Theater Inc | 09/16/2025Completed |
| Z-0323-2026 Class II | Endo Surgical Navigation Advanced Platform Patient Engagement (EndoSNAP), software…A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image… | Surgical Theater Inc | 09/16/2025Completed |
| Z-0322-2026 Class II | SyncAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software…A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image… | Surgical Theater Inc | 09/16/2025Completed |
| Z-0321-2026 Class II | Surgical Navigation Advanced Platform Patient Engagement (PE SNAP), software version…A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image… | Surgical Theater Inc | 09/16/2025Completed |
| Z-0320-2026 Class II | Surgical Navigation Advanced Platform (SNAP), software version SNP.3.12.0, imaging…A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image… | Surgical Theater Inc | 09/16/2025Completed |
| Z-0319-2026 Class II | SuRgical Planner (SRP), software version SRP.7.12.0, imaging processing radiological…A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image… | Surgical Theater Inc | 09/16/2025Completed |
| Z-0068-2026 Class II | AW Server 2.0, AW Server 3.0, AW Server 3.1, AW Server 3.2Firm has identified a security vulnerability in AW Server products. If exploited, a malicious actor could… | GE Medical Systems, SCS | 09/05/2025Open, Classified |
| Z-0030-2026 Class II | Change Healthcare Radiology Solutions software version 14.2.2Due to software issue, radiology reports may not be fully displayed when viewing. | Change Healthcare Canada Company | 08/13/2025Open, Classified |
| Z-2543-2025 Class II | IntelliSpace Cardiovascular, Software 8.0.0.4.Software issue that results in the display of outdated information. | Philips Medical Systems Nederland B.V. | 08/08/2025Open, Classified |
| Z-2297-2025 Class II | 3mensio Workstation (Vascular Fenestrated) softwareWhen fenestrated analysis with clock measurements is started in diagnostic bioimaging software (intended to… | PIE Medical Imaging B.V. | 07/14/2025Open, Classified |
| Z-1740-2025 Class II | IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.An issue was identified with the software when using the Echo Module of ISCV, the issue may result in… | Philips Medical Systems Nederland B.V. | 04/07/2025Open, Classified |
| Z-1487-2025 Class II | GE Healthcare Centricity Centricity PACS-IW with Universal Viewer, Model Numbers: 1)…There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW… | GE Healthcare | 02/19/2025Open, Classified |
| Z-1486-2025 Class II | GE Healthcare Centricity Cardiology CA1000 (CA1000), Model Numbers: 1) 2033901-001; 2)…There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW… | GE Healthcare | 02/19/2025Open, Classified |
| Z-1485-2025 Class II | GE Healthcare Centricity Radiology RA600 (RA600), Model Numbers: 1) 2022296-001; 2)…There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW… | GE Healthcare | 02/19/2025Open, Classified |
| Z-1484-2025 Class II | GE Healthcare Centricity PACS-IW (PACS-IW), Model Numbers: 1) 2042988-001; 2)…There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW… | GE Healthcare | 02/19/2025Open, Classified |
| Z-1483-2025 Class II | GE Healthcare Centricity Universal Viewer (UV), Model Numbers: 1) 2066908-077; 2)…There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW… | GE Healthcare | 02/19/2025Open, Classified |
| Z-1402-2025 Class II | Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.1, 12.1.1, 12.2…When following a specific less typical workflow in which the user remeasures using the ultrasound device or… | Merge Healthcare, Inc. | 02/19/2025Open, Classified |
| Z-1401-2025 Class II | VERICIS, Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.0.1…When following a specific less typical workflow in which the user remeasures using the ultrasound device or… | Merge Healthcare, Inc. | 02/19/2025Open, Classified |
| Z-1400-2025 Class II | VERICIS, Merge Cardio, Model/Catalog Number: Version 11.x, Software Version: 11.0.2…When following a specific less typical workflow in which the user remeasures using the ultrasound device or… | Merge Healthcare, Inc. | 02/19/2025Open, Classified |
| Z-1399-2025 Class II | VERICIS, Merge Cardio, Model/Catalog Number: Version 10.x, Software Version: 10.0…When following a specific less typical workflow in which the user remeasures using the ultrasound device or… | Merge Healthcare, Inc. | 02/19/2025Open, Classified |
| Z-1398-2025 Class II | VERICIS, Merge Cardio, Model/Catalog Number: Version 9.x, Software Version: 9.0.6 and…When following a specific less typical workflow in which the user remeasures using the ultrasound device or… | Merge Healthcare, Inc. | 02/19/2025Open, Classified |
| Z-1267-2025 Class II | MIM software; System, Image Processing, RadiologicalIn situations where two images with differing Fields of View (FOV) complete an image fusion, an incorrect… | MIM Software Inc | 02/19/2025Open, Classified |
| Z-1407-2025 Class II | Synapse PACS Software Version 7.4.x; Software Versions: 7.4.000, 7.4.001, 7.4.010…The incorrect computed patient age is showing in VX for patients less than 3 months old. | FUJIFILM Healthcare Americas Corporation | 02/11/2025Open, Classified |
| Z-1392-2025 Class II | Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1Under certain circumstances, it can occur that patient records from unrelated individuals are automatically… | Brainlab AG | 02/10/2025Open, Classified |
| Z-1208-2025 Class II | IntelePACS (Image Fusion Module) - InteleViewerA software application that receives digital images and data from various sources has a bug in specific… | Intelerad Medical Systems Incorporated | 02/05/2025Open, Classified |
| Z-1118-2025 Class II | UNiD" Adaptive Spine Intelligence UNiD Spine Analyzer Product Number SW3002 UDI-DI code…Due to software anomalies that may impact on rod planning specifically, certain optional surgical parameters… | Medicrea International | 12/03/2024Open, Classified |
| Z-0710-2025 Class II | mint Lesion, Software Versions: 3.10.0 and 3.10.1.Some software versions have a malfunction where they may show incorrect orientation labels for a specific… | Mint Medical GmbH | 11/15/2024Open, Classified |