FDA Product Code
FDA Product Code QIH — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.2050
510(k) Clearances — 334 records · page 1 of 4
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260055 | syngo.CT Brain Quantification | Siemens Medical Solutions USA, Inc. | 2026-09-25 | Traditional | PDF ↗ |
| K262390 | BoneXpert | Visiana | 2026-09-22 | Traditional | PDF ↗ |
| K261368 | Rapid Platform (R6.7) | Ischemaview, Inc. | 2026-09-21 | Traditional | PDF ↗ |
| K261623 | EchoPAC Software Only / EchoPAC Plug-in (v211) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2026-09-16 | Traditional | PDF ↗ |
| K261677 | Artificial Intelligence Renal Assessment (AIRA) Version 1 | Aramis Global AI Consultancies, LLC | 2026-09-15 | Traditional | PDF ↗ |
| K260879 | 4DM | INVIA, LLC | 2026-09-10 | Traditional | PDF ↗ |
| K261795 | Quicktome Software Suite | Omniscient Neurotechnology Pty, Ltd. | 2026-09-10 | Traditional | PDF ↗ |
| K251417 | ReVISION 2 | Argus Cognitive, Inc. | 2026-09-09 | Traditional | PDF ↗ |
| K260525 | NextMR Spine | MRI2CT, Inc. | 2026-09-04 | Traditional | PDF ↗ |
| K260811 | Heartvue.Proton | Heartvue.ai, Inc. | 2026-08-26 | Traditional | PDF ↗ |
| K261595 | Ceevra Reveal 4 | Ceevra, Inc. | 2026-08-25 | Traditional | PDF ↗ |
| K262127 | DS Core CBCT Anatomy | Dentsply Sirona | 2026-08-21 | Traditional | PDF ↗ |
| K260584 | BoneMRI | Mriguidance B.V. | 2026-08-21 | Traditional | PDF ↗ |
| K261641 | Lower Limb AI (LLAI) | AI Planning Logic, Inc. | 2026-08-18 | Traditional | PDF ↗ |
| K253794 | Prostate Core | Lucida Medical, Ltd. | 2026-08-10 | Traditional | PDF ↗ |
| K252571 | mdprostate | Mediaire GmbH | 2026-08-07 | Traditional | PDF ↗ |
| K253902 | RealGUIDE | 3DIEMME SRL | 2026-08-04 | Traditional | PDF ↗ |
| K253835 | Affinity | Hermes Medical Solutions AB | 2026-07-31 | Traditional | PDF ↗ |
| K260980 | cmAngio® V2.0 | Curemetrix, Inc. | 2026-07-30 | Traditional | PDF ↗ |
| K261210 | Cleerly Plaque | Cleerly, Inc. | 2026-07-29 | Traditional | PDF ↗ |
| K261349 | SwiftMR | Airs Medical, Inc. | 2026-07-24 | Traditional | PDF ↗ |
| K260192 | DIANA | ROPCA ApS | 2026-07-24 | Traditional | PDF ↗ |
| K254096 | VELMENI for DENTISTS (V4D) 3D | Velmeni, Inc. | 2026-07-23 | Traditional | PDF ↗ |
| K261535 | Hi-D Imaging 4TAVR | Hi-D Imaging AG | 2026-07-20 | Special | PDF ↗ |
| K260206 | SkeletonPlanner | UPlanner B.V. - Presurgeo | 2026-07-15 | Traditional | PDF ↗ |
| K260973 | InferOperate Suite | Beijing Infervision Healthcare Medical Technology Co., Ltd. | 2026-07-07 | Traditional | PDF ↗ |
| K253969 | ADAS 3D | Adas3D Medical S.L. | 2026-06-29 | Traditional | PDF ↗ |
| K253628 | Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012) | Agada Medical, Ltd. | 2026-06-29 | Traditional | PDF ↗ |
| K253786 | syngo.CT Coronary Cockpit | Siemens Medical Solutions USA, Inc. | 2026-06-25 | Traditional | PDF ↗ |
| K260316 | CMN Capillary Function with Oncology Virtual Expert | Cercare Medical A/S | 2026-06-22 | Traditional | PDF ↗ |
| K261713 | Synapse PACS (7.6.0) | FUJIFILM Healthcare Americas Corporation | 2026-06-18 | Special | PDF ↗ |
| K253172 | MediAI-OA | Crescom Co., Ltd. | 2026-06-15 | Traditional | PDF ↗ |
| K260300 | WatchMate Software | Anumana, Inc. | 2026-06-15 | Traditional | PDF ↗ |
| K253690 | LungMaps | Siemens Healthineers AG | 2026-06-15 | Traditional | PDF ↗ |
| K260406 | Brainomix 360 Hyperdensity | Brainomix Limited | 2026-06-12 | Traditional | PDF ↗ |
| K260322 | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) | Mighty Oak Medical | 2026-06-11 | Traditional | PDF ↗ |
| K260497 | DEEPVESSEL Plaque | Keya Medical Technology Co., Ltd. | 2026-06-04 | Traditional | PDF ↗ |
| K260077 | OrthoGrid Hip AI® 4.0 | OrthoGrid Systems, Inc. | 2026-05-29 | Traditional | PDF ↗ |
| K261405 | ANDI 2.2 | Imeka Solutions, Inc. | 2026-05-28 | Special | PDF ↗ |
| K260324 | Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning | Canon Medical Informatics, Inc. | 2026-05-22 | Traditional | PDF ↗ |
| K260234 | MSK Go | Smart Alfa Teknoloji San. Ve Tic. A.S. | 2026-05-21 | Traditional | PDF ↗ |
| K254131 | BAC | DeepHealth, Inc. | 2026-05-21 | Traditional | PDF ↗ |
| K261289 | UNiD Spine Analyzer (SW3002) | Medicrea International S.A.S. (Medtronic) | 2026-05-15 | Special | PDF ↗ |
| K254120 | SubtleHD-CT (1.x) | Subtle Medical, Inc. | 2026-05-15 | Traditional | PDF ↗ |
| K261273 | Neurophet AQUA | Neurophet., Inc. | 2026-05-15 | Special | PDF ↗ |
| K252563 | Neurophet SCALE PET | Neurophet., Inc. | 2026-05-15 | Traditional | PDF ↗ |
| K260032 | Morph | BeauBrain Healthcare, Inc. | 2026-05-13 | Traditional | PDF ↗ |
| K254189 | Synapse 3D Base Tools (V7.2) | Fujifilm Corporation | 2026-04-30 | Traditional | PDF ↗ |
| K254184 | syngo Application Software | Siemens Medical Solutions USA, Inc. | 2026-04-29 | Traditional | PDF ↗ |
| K260785 | DS Core CBCT Anatomy | Dentsply Sirona | 2026-04-23 | Traditional | PDF ↗ |
| K253077 | uOmnispace.MR | Shanghai United Imaging Healthcare Co., Ltd. | 2026-04-22 | Traditional | PDF ↗ |
| K252332 | Folliscan | Mim Fertility | 2026-04-20 | Traditional | PDF ↗ |
| K253502 | Critical Care Suite with Enteric Tube Positioning AI Algorithm | Ge Medical Systems, LLC | 2026-04-14 | Traditional | PDF ↗ |
| K253930 | Overjet Iris Intelligent Imaging System | Overjet, Inc. | 2026-04-10 | Traditional | PDF ↗ |
| K253689 | syngo Dynamics (VA41F) | Siemens Healthcare GmbH | 2026-04-10 | Traditional | PDF ↗ |
| K252708 | Relu Cloud | Relu BV | 2026-04-10 | Traditional | PDF ↗ |
| K254015 | CoLumbo C-Spine | Smart Soft Healthcare AD | 2026-04-01 | Traditional | PDF ↗ |
| K254207 | AiORTA - Plan v2.0 | ViTAA Medical Solutions, Inc. | 2026-03-30 | Traditional | PDF ↗ |
| K253775 | SwiftMR | Airs Medical, Inc. | 2026-03-26 | Traditional | PDF ↗ |
| K253614 | EchoNavigator R5.0 | Philips Medical Systems Nederland B.V. | 2026-03-17 | Traditional | PDF ↗ |
| K253944 | Data Analysis Facilitation Suite (DAFS) | Voronoi Health Analytics Incorporated | 2026-03-16 | Traditional | PDF ↗ |
| K252261 | InferCare RECIST | Beijing Infervision Healthcare Medical Technology Co., Ltd. | 2026-03-13 | Traditional | PDF ↗ |
| K253551 | VELYS Hip Navigation | Depuy Ireland UC | 2026-03-06 | Traditional | PDF ↗ |
| K252538 | CEPHX3D | Orca Dental AI , Ltd. | 2026-03-05 | Traditional | PDF ↗ |
| K253593 | Clarius Ejection Fraction AI | Clarius Mobile Health Corp. | 2026-03-02 | Traditional | PDF ↗ |
| K253535 | Ligence Heart | Ligence Uab | 2026-02-27 | Traditional | PDF ↗ |
| K260217 | AI Platform 2.2 (AIP002) | Exo Imaging | 2026-02-24 | Special | PDF ↗ |
| K252084 | AI4CMR v2.0 | Ai4medimaging Medical Solutions S.A. | 2026-02-11 | Special | PDF ↗ |
| K254016 | MI View&GO | Siemens Medical Solutions USA, Inc. | 2026-02-10 | Special | PDF ↗ |
| K252091 | Surgical Reality Viewer | Medicalvr B.V. | 2026-01-29 | Traditional | PDF ↗ |
| K252496 | Neurophet AQUA AD Plus | Neurophet., Inc. | 2026-01-29 | Traditional | PDF ↗ |
| K253057 | AI-Rad Companion Brain MR | Siemens Healthcare GmbH | 2026-01-22 | Traditional | PDF ↗ |
| K253735 | AV Vascular | Philips Medical Systems Nederland B.V. | 2026-01-22 | Traditional | PDF ↗ |
| K252634 | Imagine® Enterprise Suite | Softlink International Private Limited | 2026-01-16 | Traditional | PDF ↗ |
| K253532 | TruSPECT Processing Station | Spectrum Dynamics Medical, Ltd. | 2025-12-30 | Special | PDF ↗ |
| K252856 | PeekMed web | Peek Health, S.A. | 2025-12-22 | Traditional | PDF ↗ |
| K252029 | AI-CVD | HeartLung Corporation | 2025-12-19 | Traditional | PDF ↗ |
| K252670 | Alzevita | TOPIA MEDTECH LIMITED | 2025-12-19 | Traditional | PDF ↗ |
| K250914 | MediAI-BA | Crescom Co., Ltd. | 2025-12-18 | Traditional | PDF ↗ |
| K252235 | PVAD IQ Software | Ultrasight , Ltd. | 2025-12-18 | Traditional | PDF ↗ |
| K252922 | Neosoma Brain Mets | Neosoma, Inc. | 2025-12-17 | Traditional | PDF ↗ |
| K251763 | IRISeg | Intuitive Surgical, Inc. | 2025-12-16 | Traditional | PDF ↗ |
| K251514 | Overjet CBCT Assist | Overjet, Inc. | 2025-12-05 | Traditional | PDF ↗ |
| K252103 | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) | Mighty Oak Medical | 2025-12-02 | Traditional | PDF ↗ |
| K251078 | AutoDensity | Eos Imaging | 2025-11-14 | Traditional | PDF ↗ |
| K252452 | PeekMed web | Peek Health, S.A. | 2025-11-12 | Traditional | PDF ↗ |
| K250330 | 3mensio Workstation | Pie Medical Imaging BV | 2025-11-03 | Traditional | PDF ↗ |
| K250337 | AiORTA - Plan | ViTAA Medical Solutions, Inc. | 2025-10-30 | Traditional | PDF ↗ |
| K251027 | cvi42 Coronary Plaque Software Application | Circle Cardiovascular Imaging, Inc. | 2025-10-27 | Traditional | PDF ↗ |
| K251059 | Syngo Carbon Clinicals (VA41) | Siemens Healthineers AG | 2025-10-24 | Traditional | PDF ↗ |
| K250288 | TeraRecon Cardiovascular.Calcification.CT | Terarecon,Inc. | 2025-10-23 | Traditional | PDF ↗ |
| K252298 | ANDI 2.0 | Imeka Solutions, Inc. | 2025-10-22 | Traditional | PDF ↗ |
| K252665 | brAIn Shoulder Positioning | Avatar Medical | 2025-10-20 | Traditional | PDF ↗ |
| K252214 | AIAS Cephalon | Metamorphosis GmbH | 2025-10-07 | Traditional | PDF ↗ |
| K252007 | BlineSlide | Deep Breathe, Inc. | 2025-10-06 | Traditional | PDF ↗ |
| K250023 | SMART PCFD | Disior, Ltd. | 2025-09-29 | Traditional | PDF ↗ |
| K252105 | Ligence Heart | Ligence Uab | 2025-09-26 | Traditional | PDF ↗ |
| K251527 | Brain WMH | Quantib B.V. | 2025-09-25 | Traditional | PDF ↗ |
| K251483 | SwiftSight-Brain | Airs Medical, Inc. | 2025-09-23 | Traditional | PDF ↗ |
| K251987 | Rapid Aortic Measurements | Ischemaview, Inc. | 2025-09-23 | Traditional | PDF ↗ |
Product code QIH · Class II · Radiology. Data: openFDA.