Automated Radiological Image Processing Software
Regulation 892.2050
90510(k)s in 12 months (338 all time)
1recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in QIH
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 19, 2026 | K262147 | CINA-Aneurysm+ Avicenna.Ai, FR | QIH |
| Oct 7, 2026 | K262134 | NeuroDR Deep Reasoning Ai, Inc. | QIH |
| Oct 7, 2026 | K261733 | Ligence Heart UAB Ligence, LT | QIH |
| Oct 5, 2026 | K260523 | QGuideCT (1.0) Medis Medical Imaging Systems BV, NL | QIH |
| Sep 25, 2026 | K260055 | syngo.CT Brain Quantification Siemens Medical Solutions USA, Inc. | QIH |
| Sep 22, 2026 | K262390 | BoneXpert Visiana, DK | QIH |
| Sep 21, 2026 | K261368 | Rapid Platform (R6.7) Ischemaview, Inc. | QIH |
| Sep 16, 2026 | K261623 | EchoPAC Software Only / EchoPAC Plug-in (v211) GE Medical Systems Ultrasound and Primary Care Diagnostics | QIH |
| Sep 15, 2026 | K261677 | Artificial Intelligence Renal Assessment (AIRA) Version 1 Aramis Global AI Consultancies, LLC, AE | QIH |
| Sep 10, 2026 | K261795 | Quicktome Software Suite Omniscient Neurotechnology Pty, Ltd., AU | QIH |
| Sep 10, 2026 | K260879 | 4DM INVIA, LLC | QIH |
| Sep 9, 2026 | K251417 | ReVISION 2 Argus Cognitive, Inc. | QIH |
| Sep 4, 2026 | K260525 | NextMR Spine MRI2CT, Inc. | QIH |
| Aug 26, 2026 | K260811 | Heartvue.Proton Heartvue.ai, Inc. | QIH |
| Aug 25, 2026 | K261595 | Ceevra Reveal 4 Ceevra, Inc. | QIH |
| Aug 21, 2026 | K262127 | DS Core CBCT Anatomy Dentsply Sirona | QIH |
| Aug 21, 2026 | K260584 | BoneMRI Mriguidance B.V., NL | QIH |
| Aug 18, 2026 | K261641 | Lower Limb AI (LLAI) AI Planning Logic, Inc. | QIH |
| Aug 10, 2026 | K253794 | Prostate Core Lucida Medical, Ltd., GB | QIH |
| Aug 7, 2026 | K252571 | mdprostate Mediaire GmbH, DE | QIH |
| Aug 4, 2026 | K253902 | RealGUIDE 3DIEMME SRL, IT | QIH |
| Jul 31, 2026 | K253835 | Affinity Hermes Medical Solutions AB, SE | QIH |
| Jul 30, 2026 | K260980 | cmAngio® V2.0 Curemetrix, Inc. | QIH |
| Jul 29, 2026 | K261210 | Cleerly Plaque Cleerly, Inc. | QIH |
| Jul 24, 2026 | K261349 | SwiftMR Airs Medical, Inc., KR | QIH |
| Jul 24, 2026 | K260192 | DIANA ROPCA ApS, DK | QIH |
| Jul 23, 2026 | K254096 | VELMENI for DENTISTS (V4D) 3D Velmeni, Inc. | QIH |
| Jul 20, 2026 | K261535 | Hi-D Imaging 4TAVR Hi-D Imaging AG, CH | QIH |
| Jul 15, 2026 | K260206 | SkeletonPlanner UPlanner B.V. - Presurgeo, NL | QIH |
| Jul 7, 2026 | K260973 | InferOperate Suite Beijing Infervision Healthcare Medical Technology Co., Ltd., CN | QIH |
| Jun 29, 2026 | K253969 | ADAS 3D Adas3D Medical S.L., ES | QIH |
| Jun 29, 2026 | K253628 | Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012) Agada Medical, Ltd., IL | QIH |
| Jun 25, 2026 | K253786 | syngo.CT Coronary Cockpit Siemens Medical Solutions USA, Inc. | QIH |
| Jun 22, 2026 | K260316 | CMN Capillary Function with Oncology Virtual Expert Cercare Medical A/S, DK | QIH |
| Jun 18, 2026 | K261713 | Synapse PACS (7.6.0) FUJIFILM Healthcare Americas Corporation | QIH |
| Jun 15, 2026 | K260300 | WatchMate Software Anumana, Inc. | QIH |
| Jun 15, 2026 | K253690 | LungMaps Siemens Healthineers AG, DE | QIH |
| Jun 15, 2026 | K253172 | MediAI-OA Crescom Co., Ltd., KR | QIH |
| Jun 12, 2026 | K260406 | Brainomix 360 Hyperdensity Brainomix Limited, GB | QIH |
| Jun 11, 2026 | K260322 | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) Mighty Oak Medical | QIH |
| Jun 4, 2026 | K260497 | DEEPVESSEL Plaque Keya Medical Technology Co., Ltd., CN | QIH |
| May 29, 2026 | K260077 | OrthoGrid Hip AI® 4.0 OrthoGrid Systems, Inc. | QIH |
| May 28, 2026 | K261405 | ANDI 2.2 Imeka Solutions, Inc., CA | QIH |
| May 22, 2026 | K260324 | Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning Canon Medical Informatics, Inc. | QIH |
| May 21, 2026 | K260234 | MSK Go Smart Alfa Teknoloji San. Ve Tic. A.S., TR | QIH |
| May 21, 2026 | K254131 | BAC DeepHealth, Inc. | QIH |
| May 15, 2026 | K261289 | UNiD Spine Analyzer (SW3002) Medicrea International S.A.S. (Medtronic), FR | QIH |
| May 15, 2026 | K261273 | Neurophet AQUA Neurophet., Inc., KR | QIH |
| May 15, 2026 | K254120 | SubtleHD-CT (1.x) Subtle Medical, Inc. | QIH |
| May 15, 2026 | K252563 | Neurophet SCALE PET Neurophet., Inc., KR | QIH |
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