Automated Radiological Image Processing Software
FDA product code QIH · Class II (moderate risk) · 21 CFR 892.2050 · Radiology
To provide automated radiological image processing and analysis tools. Software implementing artificial intelligence including nonadaptive machine learning algorithms trained with clinical and/or artificial data. In these devices, the algorithm training data typically impacts device performance. Adaptive AI algorithms are not within scope of this product code.
329510(k) clearances
0PMA approvals
2recalls
Manufacturers
- Siemens Medical Solutions USA, Inc. 12
- Dia Imaging Analysis, Ltd. 10
- Shanghai United Imaging Healthcare Co., Ltd. 6
- Overjet, Inc. 5
- Clarius Mobile Health Corp. 5
- Ischemaview, Inc. 5
- Siemens Healthcare GmbH 5
- Coreline Soft Co., Ltd. 4
- Ceevra, Inc. 4
- Eos Imaging 4
- Qure.Ai Technologies 4
- Disior, Ltd. 4
- Mriguidance B.V. 4
- Peek Health, S.A. 4
- Aidoc Medical , Ltd. 4
- Circle Cardiovascular Imaging, Inc. 4
- Neurophet., Inc. 4
- Brainlab AG 3
- Smart Soft Healthcare AD 3
- Arterys, Inc. 3
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261795 | Quicktome Software SuiteQIH · Traditional | Omniscient Neurotechnology Pty, Ltd. | 09/10/2026SE |
| K260879 | 4DMQIH · Traditional | Invia, LLC | 09/10/2026SE |
| K251417 | ReVISION 2QIH · Traditional | Argus Cognitive, Inc. | 09/09/2026SE |
| K260525 | NextMR SpineQIH · Traditional | MRI2CT, Inc. | 09/04/2026SE |
| K260811 | Heartvue.ProtonQIH · Traditional | Heartvue.ai, Inc. | 08/26/2026SE |
| K261595 | Ceevra Reveal 4QIH · Traditional | Ceevra, Inc. | 08/25/2026SE |
| K262127 | DS Core CBCT AnatomyQIH · Traditional | Dentsply Sirona | 08/21/2026SE |
| K260584 | BoneMRIQIH · Traditional | Mriguidance B.V. | 08/21/2026SE |
| K261641 | Lower Limb AI (LLAI)QIH · Traditional | AI Planning Logic, Inc. | 08/18/2026SE |
| K253794 | Prostate CoreQIH · Traditional | Lucida Medical, Ltd. | 08/10/2026SE |
| K252571 | mdprostateQIH · Traditional | Mediaire GmbH | 08/07/2026SE |
| K253902 | RealGUIDEQIH · Traditional | 3DIEMME SRL | 08/04/2026SE |
| K253835 | AffinityQIH · Traditional | Hermes Medical Solutions AB | 07/31/2026SE |
| K260980 | cmAngio® V2.0QIH · Traditional | Curemetrix, Inc. | 07/30/2026SE |
| K261210 | Cleerly PlaqueQIH · Traditional | Cleerly, Inc. | 07/29/2026SE |
| K261349 | SwiftMRQIH · Traditional | Airs Medical, Inc. | 07/24/2026SE |
| K260192 | DianaQIH · Traditional | ROPCA ApS | 07/24/2026SE |
| K254096 | VELMENI for DENTISTS (V4D) 3DQIH · Traditional | Velmeni, Inc. | 07/23/2026SE |
| K261535 | Hi-D Imaging 4TAVRQIH · Special | Hi-D Imaging AG | 07/20/2026SE |
| K260206 | SkeletonPlannerQIH · Traditional | UPlanner B.V. - Presurgeo | 07/15/2026SE |
| K260973 | InferOperate SuiteQIH · Traditional | Beijing Infervision Healthcare Medical… | 07/07/2026SE |
| K253969 | Adas 3DQIH · Traditional | Adas3D Medical S.L. | 06/29/2026SE |
| K253628 | Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012)QIH · Traditional | Agada Medical, Ltd. | 06/29/2026SE |
| K253786 | syngo.CT Coronary CockpitQIH · Traditional | Siemens Medical Solutions USA, Inc. | 06/25/2026SE |
| K260316 | CMN Capillary Function with Oncology Virtual ExpertQIH · Traditional | Cercare Medical A/S | 06/22/2026SE |
| K261713 | Synapse PACS (7.6.0)QIH · Special | FUJIFILM Healthcare Americas Corporation | 06/18/2026SE |
| K260300 | WatchMate SoftwareQIH · Traditional | Anumana, Inc. | 06/15/2026SE |
| K253690 | LungMapsQIH · Traditional | Siemens Healthineers AG | 06/15/2026SE |
| K253172 | MediAI-OAQIH · Traditional | Crescom Co., Ltd. | 06/15/2026SE |
| K260406 | Brainomix 360 HyperdensityQIH · Traditional | Brainomix Limited | 06/12/2026SE |
| K260322 | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)QIH · Traditional | Mighty Oak Medical | 06/11/2026SE |
| K260497 | DEEPVESSEL PlaqueQIH · Traditional | Keya Medical Technology Co., Ltd. | 06/04/2026SE |
| K260077 | OrthoGrid Hip AI® 4.0QIH · Traditional | OrthoGrid Systems, Inc. | 05/29/2026SE |
| K261405 | Andi 2.2QIH · Special | Imeka Solutions, Inc. | 05/28/2026SE |
| K260324 | Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) PlanningQIH · Traditional | Canon Medical Informatics, Inc. | 05/22/2026SE |
| K260234 | MSK GoQIH · Traditional | Smart Alfa Teknoloji San. Ve Tic. A.S. | 05/21/2026SE |
| K254131 | BacQIH · Traditional | DeepHealth, Inc. | 05/21/2026SE |
| K261289 | UNiD Spine Analyzer (SW3002)QIH · Special | Medicrea International S.A.S. (Medtronic) | 05/15/2026SE |
| K261273 | Neurophet AQUAQIH · Special | Neurophet., Inc. | 05/15/2026SE |
| K254120 | SubtleHD-CT (1.x)QIH · Traditional | Subtle Medical, Inc. | 05/15/2026SE |
| K252563 | Neurophet SCALE PETQIH · Traditional | Neurophet., Inc. | 05/15/2026SE |
| K260032 | MorphQIH · Traditional | BeauBrain Healthcare, Inc. | 05/13/2026SE |
| K254189 | Synapse 3D Base Tools (V7.2)QIH · Traditional | Fujifilm Corporation | 04/30/2026SE |
| K254184 | syngo Application SoftwareQIH · Traditional | Siemens Medical Solutions USA, Inc. | 04/29/2026SE |
| K260785 | DS Core CBCT AnatomyQIH · Traditional | Dentsply Sirona | 04/23/2026SE |
| K253077 | uOmnispace.MRQIH · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 04/22/2026SE |
| K252332 | FolliscanQIH · Traditional | Mim Fertility | 04/20/2026SE |
| K253502 | Critical Care Suite with Enteric Tube Positioning AI AlgorithmQIH · Traditional | Ge Medical Systems, LLC | 04/14/2026SE |
| K253930 | Overjet Iris Intelligent Imaging SystemQIH · Traditional | Overjet, Inc. | 04/10/2026SE |
| K253689 | syngo Dynamics (VA41F)QIH · Traditional | Siemens Healthcare GmbH | 04/10/2026SE |
| K252708 | Relu CloudQIH · Traditional | Relu BV | 04/10/2026SE |
| K254015 | CoLumbo C-SpineQIH · Traditional | Smart Soft Healthcare AD | 04/01/2026SE |
| K254207 | AiORTA - Plan v2.0QIH · Traditional | ViTAA Medical Solutions, Inc. | 03/30/2026SE |
| K253775 | SwiftMRQIH · Traditional | Airs Medical, Inc. | 03/26/2026SE |
| K253614 | EchoNavigator R5.0QIH · Traditional | Philips Medical Systems Nederland B.V. | 03/17/2026SE |
| K253944 | Data Analysis Facilitation Suite (DAFS)QIH · Traditional | Voronoi Health Analytics Incorporated | 03/16/2026SE |
| K252261 | InferCare RECISTQIH · Traditional | Beijing Infervision Healthcare Medical… | 03/13/2026SE |
| K253551 | VELYS Hip NavigationQIH · Traditional | Depuy Ireland UC | 03/06/2026SE |
| K252538 | CEPHX3DQIH · Traditional | Orca Dental AI , Ltd. | 03/05/2026SE |
| K253593 | Clarius Ejection Fraction AIQIH · Traditional | Clarius Mobile Health Corp. | 03/02/2026SE |
| K253535 | Ligence HeartQIH · Traditional | Ligence Uab | 02/27/2026SE |
| K260217 | AI Platform 2.2 (AIP002)QIH · Special | Exo Imaging | 02/24/2026SE |
| K252084 | AI4CMR v2.0QIH · Special | Ai4medimaging Medical Solutions S.A. | 02/11/2026SE |
| K254016 | MI View&GOQIH · Special | Siemens Medical Solutions USA, Inc. | 02/10/2026SE |
| K252496 | Neurophet AQUA AD PlusQIH · Traditional | Neurophet., Inc. | 01/29/2026SE |
| K252091 | Surgical Reality ViewerQIH · Traditional | Medicalvr B.V. | 01/29/2026SE |
| K253735 | AV VascularQIH · Traditional | Philips Medical Systems Nederland B.V. | 01/22/2026SE |
| K253057 | AI-Rad Companion Brain MRQIH · Traditional | Siemens Healthcare GmbH | 01/22/2026SE |
| K252634 | Imagine® Enterprise SuiteQIH · Traditional | Softlink International Private Limited | 01/16/2026SE |
| K253532 | TruSPECT Processing StationQIH · Special | Spectrum Dynamics Medical, Ltd. | 12/30/2025SE |
| K252856 | PeekMed webQIH · Traditional | Peek Health, S.A. | 12/22/2025SE |
| K252670 | AlzevitaQIH · Traditional | Topia Medtech Limited | 12/19/2025SE |
| K252029 | Ai-CvdQIH · Traditional | HeartLung Corporation | 12/19/2025SE |
| K252235 | PVAD IQ SoftwareQIH · Traditional | Ultrasight , Ltd. | 12/18/2025SE |
| K250914 | MediAI-BAQIH · Traditional | Crescom Co., Ltd. | 12/18/2025SE |
| K252922 | Neosoma Brain MetsQIH · Traditional | Neosoma, Inc. | 12/17/2025SE |
| K251763 | IRISegQIH · Traditional | Intuitive Surgical, Inc. | 12/16/2025SE |
| K251514 | Overjet CBCT AssistQIH · Traditional | Overjet, Inc. | 12/05/2025SE |
| K252103 | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)QIH · Traditional | Mighty Oak Medical | 12/02/2025SE |
| K251078 | AutoDensityQIH · Traditional | Eos Imaging | 11/14/2025SE |
| K252452 | PeekMed webQIH · Traditional | Peek Health, S.A. | 11/12/2025SE |
| K250330 | 3mensio WorkstationQIH · Traditional | Pie Medical Imaging BV | 11/03/2025SE |
| K250337 | AiORTA - PlanQIH · Traditional | ViTAA Medical Solutions, Inc. | 10/30/2025SE |
| K251027 | cvi42 Coronary Plaque Software ApplicationQIH · Traditional | Circle Cardiovascular Imaging, Inc. | 10/27/2025SE |
| K251059 | Syngo Carbon Clinicals (VA41)QIH · Traditional | Siemens Healthineers AG | 10/24/2025SE |
| K250288 | TeraRecon Cardiovascular.Calcification.CTQIH · Traditional | Terarecon,Inc. | 10/23/2025SE |
| K252298 | Andi 2.0QIH · Traditional | Imeka Solutions, Inc. | 10/22/2025SE |
| K252665 | brAIn Shoulder PositioningQIH · Traditional | Avatar Medical | 10/20/2025SE |
| K252214 | AIAS CephalonQIH · Traditional | Metamorphosis GmbH | 10/07/2025SE |
| K252007 | BlineSlideQIH · Traditional | Deep Breathe, Inc. | 10/06/2025SE |
| K250023 | Smart PCFDQIH · Traditional | Disior, Ltd. | 09/29/2025SE |
| K252105 | Ligence HeartQIH · Traditional | Ligence Uab | 09/26/2025SE |
| K251527 | Brain WMHQIH · Traditional | Quantib B.V. | 09/25/2025SE |
| K251987 | Rapid Aortic MeasurementsQIH · Traditional | Ischemaview, Inc. | 09/23/2025SE |
| K251483 | SwiftSight-BrainQIH · Traditional | Airs Medical, Inc. | 09/23/2025SE |
| K250369 | Axial3D InsightQIH · Traditional | Axial Medical Printing Limited | 09/18/2025SE |
| K250237 | InferOperate SuiteQIH · Traditional | Beijing Infervision Healthcare Medical… | 09/15/2025SE |
| K244002 | AngioWaveNetQIH · Traditional | Angiowave Imaging, Inc. | 09/10/2025SE |
| K251072 | Segmentron ViewerQIH · Traditional | Dgnct, LLC | 09/09/2025SE |
| K251656 | Careverse CoronaryDoc (Careverse CoronaryDoc)QIH · Traditional | Careverse Technology Pte. , Ltd. | 09/04/2025SE |
| K252539 | Tempus PixelQIH · Special | Arterys, Inc. | 09/03/2025SE |
| K243859 | PRAEVAorta®2QIH · Traditional | Nurea | 08/29/2025SE |
| K250947 | VistaSoft 4.0 and VisionX 4.0QIH · Traditional | Durr Dental SE | 08/27/2025SE |
| K252362 | GBrain MRIQIH · Special | Galileo Cds, Inc. | 08/22/2025SE |
| K243685 | MammoScreen BDQIH · Traditional | Therapixel | 08/22/2025SE |
| K251837 | Salix Coronary Plaque (V1.0.0)QIH · Traditional | Artrya Limited | 08/20/2025SE |
| K251747 | VEA Align; spineEOSQIH · Traditional | Eos Imaging | 08/15/2025SE |
| K250755 | DS Core DiagnosisQIH · Traditional | Dentsply Sirona, Inc. | 08/12/2025SE |
| K251629 | UNiD Spine AnalyzerQIH · Traditional | Medicrea International S.A.S. (Medtronic) | 08/07/2025SE |
| K243919 | Voxel Dosimetry (00859873006226)QIH · Traditional | Hermes Medical Solutions AB | 07/30/2025SE |
| K251342 | EchoPAC Software Only / EchoPAC Plug-inQIH · Traditional | GE Medical Systems Ultrasound and Primary Care… | 07/16/2025SE |
| K251096 | PeekMed webQIH · Traditional | Peek Health, S.A. | 07/14/2025SE |
| K251766 | TumorSight VizQIH · Special | SimBioSys, Inc. | 07/08/2025SE |
| K251528 | syngo.via MI Workflows; Scenium; syngo MBFQIH · Traditional | Siemens Medical Solutions USA, Inc. | 07/03/2025SE |
| K243779 | Bunkerhill Abdominal Aortic Quantification (AAQ)QIH · Traditional | BunkerHill Health | 07/01/2025SE |
| K250670 | EchoConfidence (USA)QIH · Abbreviated | Mycardium AI Limited | 06/30/2025SE |
| K250484 | PIUR tUS insideQIH · Traditional | Piur Imaging GmbH | 06/30/2025SE |
| K243647 | Synapse PACS (7.5)QIH · Traditional | FUJIFILM Healthcare Americas Corporation | 06/30/2025SE |
| K243633 | Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image…QIH · Traditional | Brainlab AG | 06/13/2025SE |
| K250354 | Viz Subdural+, Viz SUBDURAL PLUSQIH · Traditional | Viz. Ai, Inc. | 06/10/2025SE |
| K251009 | Cirrus Resting State fMRI SoftwareQIH · Traditional | Sora Neuroscience, Inc. | 06/06/2025SE |
| K251456 | BrightHeart View ClassifierQIH · Special | Brightheart | 06/05/2025SE |
| K243810 | TraumaCad Neo (1.1)QIH · Traditional | Brainlab , Ltd. | 06/04/2025SE |
| K243863 | Opulus Lymphoma PrecisionQIH · Traditional | Roche Molecular Systems, Inc. | 05/30/2025SE |
| K243005 | AudaxCeph Cephalogram Analysis SoftwareQIH · Traditional | Audax D.O.O. | 05/30/2025SE |
| K250367 | CoLumboXQIH · Traditional | Smart Soft Healthcare AD | 05/28/2025SE |
| K243378 | Rapid MLSQIH · Traditional | Ischemaview, Inc. | 05/28/2025SE |
| K250005 | Clever OneQIH · Traditional | Ewoosoft Co., Ltd. | 05/23/2025SE |
| K243989 | Second Opinion® 3DQIH · Traditional | Pearl, Inc. | 05/23/2025SE |
| K243762 | Synapse 3D Base Tools (V7.0)QIH · Traditional | Fujifilm Corporation | 05/21/2025SE |
| K242624 | Medical Image Post-processing Software (uOmnispace.CT)QIH · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 05/14/2025SE |
| K243230 | Second Opinion® BLEQIH · Traditional | Pearl, Inc. | 05/09/2025SE |
| K250226 | Clarius Median Nerve AIQIH · Traditional | Clarius Mobile Health Corp. | 05/08/2025SE |
| K243684 | BrightHeart View ClassifierQIH · Traditional | Brightheart | 05/07/2025SE |
| K250328 | UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis ProgramQIH · Traditional | Canon Medical Systems Corporation | 04/30/2025SE |
| K243853 | Clarius Prostate AIQIH · Traditional | Clarius Mobile Health Corp. | 04/16/2025SE |
| K242500 | LaralabQIH · Traditional | Laralab GmbH | 04/16/2025SE |
| K250416 | GBrain MRIQIH · Traditional | Galileo Cds, Inc. | 04/11/2025SE |
| K250754 | cmAngio® (V1.6)QIH · Special | Curemetrix, Inc. | 04/10/2025SE |
| K241982 | DeepFoqus (DeepFoqus-Accelerate)QIH · Traditional | Foqus Technologies, Inc. | 04/04/2025SE |
| K242551 | syngo Dynamics (Version VA41D)QIH · Traditional | Siemens Healthcare GmbH | 04/03/2025SE |
| K241984 | Hi-D Imaging 4TAVRQIH · Traditional | Hi-D Imaging AG | 04/02/2025SE |
| K242166 | TribusConnectQIH · Traditional | Tribusmed Beheer BV | 03/31/2025SE |
| K243038 | Salix CentralQIH · Traditional | Artrya Limited | 03/27/2025SE |
| K241961 | Vent Creativity Knee v1.0 (Hermes)QIH · Traditional | Vent Creativity | 03/20/2025SE |
| K250042 | PeekMed webQIH · Traditional | Peek Health, S.A. | 03/19/2025SE |
| K243689 | AviewQIH · Special | Coreline Soft Co., Ltd. | 03/19/2025SE |
| K243862 | LVivo Software ApplicationQIH · Special | Dia Imaging Analysis, Ltd. | 03/17/2025SE |
| K242338 | Cleerly LABS (v2.0)QIH · Special | Cleerly, Inc. | 03/07/2025SE |
| K243331 | LVivo SeamlessQIH · Special | Dia Imaging Analysis, Ltd. | 03/06/2025SE |
| K243933 | Ceevra Reveal 3+QIH · Traditional | Ceevra, Inc. | 03/04/2025SE |
| K243235 | LVivo Software ApplicationQIH · Traditional | Dia Imaging Analysis, Ltd. | 03/03/2025SE |
| K241922 | MyomicsQIH · Traditional | Phantomics, Inc. | 02/28/2025SE |
| K241222 | Ventripoint Medical System Plus (VMS+) 4.0QIH · Traditional | Ventripoint Diagnostics , Ltd. | 02/26/2025SE |
| K242607 | ScanDiags Ortho L-Spine MR-QQIH · Traditional | Scandiags AG | 02/21/2025SE |
| K243696 | Aview CacQIH · Special | Coreline Soft Co., Ltd. | 02/14/2025SE |
| K243250 | SubtleHD (1.x)QIH · Traditional | Subtle Medical, Inc. | 02/12/2025SE |
| K241659 | Ultrasound Workspace (UWS 6.0)QIH · Traditional | Philips Ultrasound, LLC | 02/10/2025SE |
| K241593 | BoneMetrics (US)QIH · Traditional | Gleamer Sas | 02/05/2025SE |
| K243158 | TeraRecon Aorta.CT (1.1.0)QIH · Traditional | Terarecon,Inc. | 01/23/2025SE |
| K243350 | Rapid Neuro3DQIH · Traditional | Ischemaview, Inc. | 01/22/2025SE |
| K242334 | Ezra FlashQIH · Traditional | Ezra Ai, Inc. | 01/02/2025SE |
| K241696 | Ortho AIQIH · Traditional | Ortho Ai, LLC | 01/02/2025SE |
| K243705 | Saige-Density (2.5.0)QIH · Special | DeepHealth, Inc. | 12/19/2024SE |
| K242270 | OrthoNext Platform SystemQIH · Traditional | Orthofix Srl | 12/19/2024SE |
| K240793 | MSKaiQIH · Traditional | Mskai | 12/16/2024SE |
| K242461 | IRISegQIH · Traditional | Intuitive Surgical, Inc. | 12/10/2024SE |
| K241543 | DrAid for Liver SegmentationQIH · Traditional | Vinbrain Joint Stock Company | 12/06/2024SE |
| K240680 | CDM InsightsQIH · Traditional | Oxford Brain Diagnostics, Ltd. | 12/06/2024SE |
| K240645 | Sonix HealthQIH · Traditional | Ontact Health Co., Ltd. | 11/27/2024SE |
| K242203 | BriefCase-QuantificationQIH · Traditional | Aidoc Medical , Ltd. | 11/22/2024SE |
| K242359 | Strain AI (SAI001)QIH · Traditional | Exo, Inc. | 11/20/2024SE |
| K241312 | TeraRecon Cardiac.Chambers.MR (1.0.0)QIH · Traditional | Terarecon,Inc. | 11/05/2024SE |
| K241108 | RemedyLogic AI MRI Lumbar Spine ReaderQIH · Traditional | Remedy Logic, Inc. | 10/30/2024SE |
| K243189 | TumorSight VizQIH · Special | SimBioSys, Inc. | 10/25/2024SE |
| K242215 | Neurophet AQUA (V3.1)QIH · Traditional | Neurophet., Inc. | 10/25/2024SE |
| K242781 | cvi42 Software ApplicationQIH · Special | Circle Cardiovascular Imaging, Inc. | 10/15/2024SE |
| K241430 | EchoMeasureQIH · Traditional | Icardio.Ai | 10/10/2024SE |
| K240786 | AutoChamberQIH · Traditional | HeartLung Corporation | 10/10/2024SE |
| K240553 | LVivo Software ApplicationQIH · Special | Dia Imaging Analysis, Ltd. | 10/04/2024SE |
| K241561 | MammoScreen BDQIH · Traditional | Therapixel | 10/02/2024SE |
| K240943 | LungVisionQIH · Traditional | Bodyvision Medical , Ltd. | 10/01/2024SE |
| K240036 | PIUR tUS InfinityQIH · Traditional | Piur Imaging GmbH | 09/20/2024SE |
| K241280 | Constellation (CON-001)QIH · Traditional | Q Bio, Inc. | 09/12/2024SE |
| K240094 | LumiNE US; LumiQIH · Traditional | Augmedit B.V. | 09/10/2024SE |
| K241681 | Overjet Image Enhancement AssistQIH · Traditional | Overjet, Inc. | 09/09/2024SE |
| K240791 | Adas 3DQIH · Traditional | Adas3D Medical S.L. | 09/09/2024SE |
| K240411 | uAI PortalQIH · Traditional | Shanghai United Imaging Intelligence Co., Ltd. | 09/06/2024SE |
| K242300 | MI View&GOQIH · Special | Siemens Medical Solutions USA, Inc. | 08/30/2024SE |
| K242275 | syngo.via MI Workflows; Scenium; syngo MBFQIH · Special | Siemens Medical Solutions USA, Inc. | 08/30/2024SE |
| K241847 | Imbio PHA (4.0.0)QIH · Special | Imbio, Inc. | 08/30/2024SE |
| K241684 | Overjet Charting AssistQIH · Traditional | Overjet, Inc. | 08/27/2024SE |
| K241098 | NeuroQuantQIH · Traditional | Cortechs Labs, Inc. | 08/22/2024SE |
| K240740 | qCT LN QuantQIH · Traditional | Qure.Ai Technologies | 08/16/2024SE |
| K241211 | CoLumboQIH · Traditional | Smart Soft Healthcare | 08/15/2024SE |
| K242054 | OptimMRI (v2)QIH · Special | Rebrain, Sas | 08/12/2024SE |
| K233822 | i2ContourQIH · Traditional | Mrimath, LLC | 08/08/2024SE |
| K240953 | AI Platform 2.0 (AIP002)QIH · Traditional | Exo Imaging | 08/05/2024SE |
| K234009 | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)QIH · Traditional | Mighty Oak Medical | 07/12/2024SE |
| K233457 | RusQIH · Traditional | Hutom, Inc. | 07/12/2024SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2767-2026 Class II | 3mensio Workstation (Vascular Fenestrated) softwareUser measurement value reported by diagnostic bioimaging software intended to measure/visualize… | PIE Medical Imaging B.V. | 05/07/2026Open, Classified |
| Z-2111-2021 Class II | Version: 1.2.0 (1.2.0+85ela410) Caption Health, Caption AI, Ultrasound Imaging System…The firm is aware of a issue with ultrasound software that results in unintended video frames being… | Caption Health | 05/19/2021Terminated |