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 |
|---|---|---|---|
| Sep 26, 2025 | K252105 | Ligence Heart Ligence Uab, LT | QIH |
| Sep 25, 2025 | K251527 | Brain WMH Quantib B.V., NL | QIH |
| Sep 23, 2025 | K251987 | Rapid Aortic Measurements Ischemaview, Inc. | QIH |
| Sep 23, 2025 | K251483 | SwiftSight-Brain Airs Medical, Inc., KR | QIH |
| Sep 18, 2025 | K250369 | Axial3D Insight Axial Medical Printing Limited, GB | QIH |
| Sep 15, 2025 | K250237 | InferOperate Suite Beijing Infervision Healthcare Medical Technology Co., Ltd., CN | QIH |
| Sep 10, 2025 | K244002 | AngioWaveNet Angiowave Imaging, Inc. | QIH |
| Sep 9, 2025 | K251072 | Segmentron Viewer DGNCT, LLC | QIH |
| Sep 4, 2025 | K251656 | Careverse CoronaryDoc (Careverse CoronaryDoc) Careverse Technology Pte. , Ltd., SG | QIH |
| Sep 3, 2025 | K252539 | Tempus Pixel Arterys, Inc. | QIH |
| Aug 29, 2025 | K243859 | PRAEVAorta®2 Nurea, FR | QIH |
| Aug 27, 2025 | K250947 | VistaSoft 4.0 and VisionX 4.0 Durr Dental SE, DE | QIH |
| Aug 22, 2025 | K252362 | GBrain MRI Galileo Cds, Inc. | QIH |
| Aug 22, 2025 | K243685 | MammoScreen BD Therapixel, FR | QIH |
| Aug 20, 2025 | K251837 | Salix Coronary Plaque (V1.0.0) Artrya Limited, AU | QIH |
| Aug 15, 2025 | K251747 | VEA Align; spineEOS Eos Imaging, FR | QIH |
| Aug 12, 2025 | K250755 | DS Core Diagnosis Dentsply Sirona, Inc. | QIH |
| Aug 7, 2025 | K251629 | UNiD Spine Analyzer Medicrea International S.A.S. (Medtronic), FR | QIH |
| Jul 30, 2025 | K243919 | Voxel Dosimetry (00859873006226) Hermes Medical Solutions AB, SE | QIH |
| Jul 16, 2025 | K251342 | EchoPAC Software Only / EchoPAC Plug-in GE Medical Systems Ultrasound and Primary Care Diagnostics | QIH |
| Jul 14, 2025 | K251096 | PeekMed web Peek Health, S.A., PT | QIH |
| Jul 8, 2025 | K251766 | TumorSight Viz SimBioSys, Inc. | QIH |
| Jul 3, 2025 | K251528 | syngo.via MI Workflows; Scenium; syngo MBF Siemens Medical Solutions USA, Inc. | QIH |
| Jul 1, 2025 | K243779 | Bunkerhill Abdominal Aortic Quantification (AAQ) BunkerHill Health | QIH |
| Jun 30, 2025 | K250670 | EchoConfidence (USA) Mycardium AI Limited, GB | QIH |
| Jun 30, 2025 | K250484 | PIUR tUS inside Piur Imaging GmbH, AT | QIH |
| Jun 30, 2025 | K243647 | Synapse PACS (7.5) FUJIFILM Healthcare Americas Corporation | QIH |
| Jun 13, 2025 | K243633 | Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image Fusion Angio (1.0); Brainlab Elem Brainlab AG, DE | QIH |
| Jun 10, 2025 | K250354 | Viz Subdural+, Viz SUBDURAL PLUS Viz. Ai, Inc. | QIH |
| Jun 6, 2025 | K251009 | Cirrus Resting State fMRI Software Sora Neuroscience, Inc. | QIH |
| Jun 5, 2025 | K251456 | BrightHeart View Classifier Brightheart, FR | QIH |
| Jun 4, 2025 | K243810 | TraumaCad Neo (1.1) Brainlab , Ltd., IL | QIH |
| May 30, 2025 | K243863 | Opulus Lymphoma Precision Roche Molecular Systems, Inc. | QIH |
| May 30, 2025 | K243005 | AudaxCeph Cephalogram Analysis Software Audax D.O.O., SI | QIH |
| May 28, 2025 | K250367 | CoLumboX Smart Soft Healthcare AD, BG | QIH |
| May 28, 2025 | K243378 | Rapid MLS Ischemaview, Inc. | QIH |
| May 23, 2025 | K250005 | Clever One Ewoosoft Co., Ltd., KR | QIH |
| May 23, 2025 | K243989 | Second Opinion® 3D Pearl, Inc. | QIH |
| May 21, 2025 | K243762 | Synapse 3D Base Tools (V7.0) Fujifilm Corporation, JP | QIH |
| May 14, 2025 | K242624 | Medical Image Post-processing Software (uOmnispace.CT) Shanghai United Imaging Healthcare Co., Ltd., CN | QIH |
| May 9, 2025 | K243230 | Second Opinion® BLE Pearl, Inc. | QIH |
| May 8, 2025 | K250226 | Clarius Median Nerve AI Clarius Mobile Health Corp., CA | QIH |
| May 7, 2025 | K243684 | BrightHeart View Classifier Brightheart, FR | QIH |
| Apr 30, 2025 | K250328 | UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program Canon Medical Systems Corporation, JP | QIH |
| Apr 16, 2025 | K243853 | Clarius Prostate AI Clarius Mobile Health Corp., CA | QIH |
| Apr 16, 2025 | K242500 | LARALAB Laralab GmbH, DE | QIH |
| Apr 11, 2025 | K250416 | GBrain MRI Galileo Cds, Inc. | QIH |
| Apr 10, 2025 | K250754 | cmAngio® (V1.6) Curemetrix, Inc. | QIH |
| Apr 4, 2025 | K241982 | DeepFoqus (DeepFoqus-Accelerate) Foqus Technologies, Inc., CA | QIH |
| Apr 3, 2025 | K242551 | syngo Dynamics (Version VA41D) Siemens Healthcare GmbH, DE | QIH |
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