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 |
|---|---|---|---|
| Apr 4, 2022 | K212624 | EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System Ever Fortune.Ai, Co., Ltd., TW | QIH |
| Mar 16, 2022 | K213779 | Customize 3D-Side S.A., BE | QIH |
| Mar 14, 2022 | K203744 | Arterys MICA Arterys, Inc. | QIH |
| Jan 19, 2022 | K212012 | Follicle Clarity Cycle Clarity | QIH |
| Jan 19, 2022 | K210747 | Caption Interpretation Automated Ejection Fraction Software Caption Health | QIH |
| Jan 6, 2022 | K213544 | TOMTEC-ARENA Tomtec Imaging Systems GmbH, DE | QIH |
| Dec 22, 2021 | K202404 | BoneMRI Mriguidance B.V., NL | QIH |
| Dec 21, 2021 | K212690 | qXR-BT Qure.Ai Technologies, IN | QIH |
| Dec 20, 2021 | K213275 | EchoGo Core (2.0) Ultromics Limited, GB | QIH |
| Dec 9, 2021 | K212466 | LVivo Seamless Dia Imaging Analysis, Ltd., IL | QIH |
| Nov 19, 2021 | K210831 | OnQ Neuro Cortechs Labs, Inc. | QIH |
| Oct 29, 2021 | K211161 | Critical Care Suite with Endotracheal Tube Positing AI algorithm Ge Medical Systems, LLC | QIH |
| Sep 10, 2021 | K203785 | ClariSIGMAM Claripi, Inc., KR | QIH |
| Sep 8, 2021 | K203555 | AmCAD-UT Amcad Biomed Corporation, TW | QIH |
| Aug 2, 2021 | K211431 | breastscape v1.0 Olea Medical, FR | QIH |
| Jul 30, 2021 | K211222 | qER-Quant Qure.Ai Technologies, IN | QIH |
| Jul 27, 2021 | K210791 | Us2.v1 Eko.Ai Pte Ltd. D/B/A Us2.Ai, SG | QIH |
| Jul 20, 2021 | K210719 | Change Healthcare Anatomical AI Change Healthcare Canada Company, CA | QIH |
| Jul 12, 2021 | K211506 | PowerLook Density Assessment V4.0 Icad, Inc. | QIH |
| Jun 10, 2021 | K211459 | syngo.via MI WorkFlows, Scenium, syngo MBF Siemens Medical Solutions USA, Inc. | QIH |
| Apr 23, 2021 | K203502 | MEDO-Thyroid Medo DX Pte. , Ltd., CA | QIH |
| Apr 21, 2021 | K210556 | Preview Shoulder Genesis Software Innovations | QIH |
| Mar 9, 2021 | K203256 | Imbio RV/LV Software Imbio, LLC | QIH |
| Feb 5, 2021 | K210053 | LVivo Software Application Dia Imaging Analysis, Ltd., IL | QIH |
| Jan 29, 2021 | K201411 | Visage Breast Density Visage Imaging GmbH, DE | QIH |
| Nov 18, 2020 | K201195 | syngo.via MI Workflows, syngo MBF Siemens Medical Solutions USA, Inc. | QIH |
| Oct 30, 2020 | K202013 | WRDensity by Whiterabbit.ai Whiterabbit.Ai, Inc. | QIH |
| Sep 29, 2020 | K202546 | LVivo Seamless Dia Imaging Analysis, Ltd., IL | QIH |
| Jul 30, 2020 | K193283 | AI-Rad Companion Prostate MR Siemens Medical Solutions USA, Inc. | QIH |
| Jul 22, 2020 | K200621 | Caption Interpretation Automated Ejection Fraction Software Caption Health | QIH |
| Jul 10, 2020 | K192969 | Ezra Plexo Software Ezra Ai, Inc. | QIH |
| Jun 23, 2020 | K200232 | LVivo Software Application Dia Imaging Analysis, Ltd., IL | QIH |
| Jun 11, 2020 | K200356 | MEDO ARIA Medo.Ai, CA | QIH |
| Jun 3, 2020 | K200974 | QLAB Advanced Quantification Software Philips Health Care | QIH |
| Jun 1, 2020 | K192601 | uWS-MR Shanghai United Imaging Healthcare Co., Ltd., CN | QIH |
| Mar 25, 2020 | K192437 | Arterys MICA Arterys, Inc. | QIH |
| Dec 20, 2019 | K191647 | QLAB Advanced Quantification Software Philips Health Care | QIH |
| Nov 13, 2019 | K191171 | EchoGo Core Ultromics, Ltd., GB | QIH |
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