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 |
|---|---|---|---|
| May 13, 2026 | K260032 | Morph BeauBrain Healthcare, Inc., KR | QIH |
| Apr 30, 2026 | K254189 | Synapse 3D Base Tools (V7.2) Fujifilm Corporation, JP | QIH |
| Apr 29, 2026 | K254184 | syngo Application Software Siemens Medical Solutions USA, Inc. | QIH |
| Apr 23, 2026 | K260785 | DS Core CBCT Anatomy Dentsply Sirona | QIH |
| Apr 22, 2026 | K253077 | uOmnispace.MR Shanghai United Imaging Healthcare Co., Ltd., CN | QIH |
| Apr 20, 2026 | K252332 | Folliscan Mim Fertility, PL | QIH |
| Apr 14, 2026 | K253502 | Critical Care Suite with Enteric Tube Positioning AI Algorithm Ge Medical Systems, LLC | QIH |
| Apr 10, 2026 | K253930 | Overjet Iris Intelligent Imaging System Overjet, Inc. | QIH |
| Apr 10, 2026 | K253689 | syngo Dynamics (VA41F) Siemens Healthcare GmbH, DE | QIH |
| Apr 10, 2026 | K252708 | Relu Cloud Relu BV, BE | QIH |
| Apr 1, 2026 | K254015 | CoLumbo C-Spine Smart Soft Healthcare AD, BG | QIH |
| Mar 30, 2026 | K254207 | AiORTA - Plan v2.0 ViTAA Medical Solutions, Inc., CA | QIH |
| Mar 26, 2026 | K253775 | SwiftMR Airs Medical, Inc., KR | QIH |
| Mar 17, 2026 | K253614 | EchoNavigator R5.0 Philips Medical Systems Nederland B.V., NL | QIH |
| Mar 16, 2026 | K253944 | Data Analysis Facilitation Suite (DAFS) Voronoi Health Analytics Incorporated, CA | QIH |
| Mar 13, 2026 | K252261 | InferCare RECIST Beijing Infervision Healthcare Medical Technology Co., Ltd., CN | QIH |
| Mar 6, 2026 | K253551 | VELYS Hip Navigation Depuy Ireland UC, IE | QIH |
| Mar 5, 2026 | K252538 | CEPHX3D Orca Dental AI , Ltd., IL | QIH |
| Mar 2, 2026 | K253593 | Clarius Ejection Fraction AI Clarius Mobile Health Corp., CA | QIH |
| Feb 27, 2026 | K253535 | Ligence Heart Ligence Uab, LT | QIH |
| Feb 24, 2026 | K260217 | AI Platform 2.2 (AIP002) Exo Imaging | QIH |
| Feb 11, 2026 | K252084 | AI4CMR v2.0 Ai4medimaging Medical Solutions S.A., PT | QIH |
| Feb 10, 2026 | K254016 | MI View&GO Siemens Medical Solutions USA, Inc. | QIH |
| Jan 29, 2026 | K252496 | Neurophet AQUA AD Plus Neurophet., Inc., KR | QIH |
| Jan 29, 2026 | K252091 | Surgical Reality Viewer Medicalvr B.V., NL | QIH |
| Jan 22, 2026 | K253735 | AV Vascular Philips Medical Systems Nederland B.V., NL | QIH |
| Jan 22, 2026 | K253057 | AI-Rad Companion Brain MR Siemens Healthcare GmbH, DE | QIH |
| Jan 16, 2026 | K252634 | Imagine® Enterprise Suite Softlink International Private Limited, IN | QIH |
| Dec 30, 2025 | K253532 | TruSPECT Processing Station Spectrum Dynamics Medical, Ltd., IL | QIH |
| Dec 22, 2025 | K252856 | PeekMed web Peek Health, S.A., PT | QIH |
| Dec 19, 2025 | K252670 | Alzevita TOPIA MEDTECH LIMITED, GB | QIH |
| Dec 19, 2025 | K252029 | AI-CVD HeartLung Corporation | QIH |
| Dec 18, 2025 | K252235 | PVAD IQ Software Ultrasight , Ltd., IL | QIH |
| Dec 18, 2025 | K250914 | MediAI-BA Crescom Co., Ltd., KR | QIH |
| Dec 17, 2025 | K252922 | Neosoma Brain Mets Neosoma, Inc. | QIH |
| Dec 16, 2025 | K251763 | IRISeg Intuitive Surgical, Inc. | QIH |
| Dec 5, 2025 | K251514 | Overjet CBCT Assist Overjet, Inc. | QIH |
| Dec 2, 2025 | K252103 | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) Mighty Oak Medical | QIH |
| Nov 14, 2025 | K251078 | AutoDensity Eos Imaging, FR | QIH |
| Nov 12, 2025 | K252452 | PeekMed web Peek Health, S.A., PT | QIH |
| Nov 3, 2025 | K250330 | 3mensio Workstation Pie Medical Imaging BV, NL | QIH |
| Oct 30, 2025 | K250337 | AiORTA - Plan ViTAA Medical Solutions, Inc., CA | QIH |
| Oct 27, 2025 | K251027 | cvi42 Coronary Plaque Software Application Circle Cardiovascular Imaging, Inc., CA | QIH |
| Oct 24, 2025 | K251059 | Syngo Carbon Clinicals (VA41) Siemens Healthineers AG, DE | QIH |
| Oct 23, 2025 | K250288 | TeraRecon Cardiovascular.Calcification.CT Terarecon,Inc. | QIH |
| Oct 22, 2025 | K252298 | ANDI 2.0 Imeka Solutions, Inc., CA | QIH |
| Oct 20, 2025 | K252665 | brAIn Shoulder Positioning Avatar Medical, FR | QIH |
| Oct 7, 2025 | K252214 | AIAS Cephalon Metamorphosis GmbH, DE | QIH |
| Oct 6, 2025 | K252007 | BlineSlide Deep Breathe, Inc., CA | QIH |
| Sep 29, 2025 | K250023 | SMART PCFD Disior, Ltd., FI | QIH |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.