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 2 of 4
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K250369 | Axial3D Insight | Axial Medical Printing Limited | 2025-09-18 | Traditional | PDF ↗ |
| K250237 | InferOperate Suite | Beijing Infervision Healthcare Medical Technology Co., Ltd. | 2025-09-15 | Traditional | PDF ↗ |
| K244002 | AngioWaveNet | Angiowave Imaging, Inc. | 2025-09-10 | Traditional | PDF ↗ |
| K251072 | Segmentron Viewer | DGNCT, LLC | 2025-09-09 | Traditional | PDF ↗ |
| K251656 | Careverse CoronaryDoc (Careverse CoronaryDoc) | Careverse Technology Pte. , Ltd. | 2025-09-04 | Traditional | PDF ↗ |
| K252539 | Tempus Pixel | Arterys, Inc. | 2025-09-03 | Special | PDF ↗ |
| K243859 | PRAEVAorta®2 | Nurea | 2025-08-29 | Traditional | PDF ↗ |
| K250947 | VistaSoft 4.0 and VisionX 4.0 | Durr Dental SE | 2025-08-27 | Traditional | PDF ↗ |
| K252362 | GBrain MRI | Galileo Cds, Inc. | 2025-08-22 | Special | PDF ↗ |
| K243685 | MammoScreen BD | Therapixel | 2025-08-22 | Traditional | PDF ↗ |
| K251837 | Salix Coronary Plaque (V1.0.0) | Artrya Limited | 2025-08-20 | Traditional | PDF ↗ |
| K251747 | VEA Align; spineEOS | Eos Imaging | 2025-08-15 | Traditional | PDF ↗ |
| K250755 | DS Core Diagnosis | Dentsply Sirona, Inc. | 2025-08-12 | Traditional | PDF ↗ |
| K251629 | UNiD Spine Analyzer | Medicrea International S.A.S. (Medtronic) | 2025-08-07 | Traditional | PDF ↗ |
| K243919 | Voxel Dosimetry (00859873006226) | Hermes Medical Solutions AB | 2025-07-30 | Traditional | PDF ↗ |
| K251342 | EchoPAC Software Only / EchoPAC Plug-in | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2025-07-16 | Traditional | PDF ↗ |
| K251096 | PeekMed web | Peek Health, S.A. | 2025-07-14 | Traditional | PDF ↗ |
| K251766 | TumorSight Viz | SimBioSys, Inc. | 2025-07-08 | Special | PDF ↗ |
| K251528 | syngo.via MI Workflows; Scenium; syngo MBF | Siemens Medical Solutions USA, Inc. | 2025-07-03 | Traditional | PDF ↗ |
| K243779 | Bunkerhill Abdominal Aortic Quantification (AAQ) | BunkerHill Health | 2025-07-01 | Traditional | PDF ↗ |
| K250484 | PIUR tUS inside | Piur Imaging GmbH | 2025-06-30 | Traditional | PDF ↗ |
| K250670 | EchoConfidence (USA) | Mycardium AI Limited | 2025-06-30 | Abbreviated | PDF ↗ |
| K243647 | Synapse PACS (7.5) | FUJIFILM Healthcare Americas Corporation | 2025-06-30 | Traditional | PDF ↗ |
| K243633 | Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image Fusion Angio (1.0); Brainlab Elements Contouring (5.0); Brainlab Elements Fibertracking (3.0); Brainlab Elements BOLD MRI Mapping (1.0) | Brainlab AG | 2025-06-13 | Traditional | PDF ↗ |
| K250354 | Viz Subdural+, Viz SUBDURAL PLUS | Viz. Ai, Inc. | 2025-06-10 | Traditional | PDF ↗ |
| K251009 | Cirrus Resting State fMRI Software | Sora Neuroscience, Inc. | 2025-06-06 | Traditional | PDF ↗ |
| K251456 | BrightHeart View Classifier | Brightheart | 2025-06-05 | Special | PDF ↗ |
| K243810 | TraumaCad Neo (1.1) | Brainlab , Ltd. | 2025-06-04 | Traditional | PDF ↗ |
| K243005 | AudaxCeph Cephalogram Analysis Software | Audax D.O.O. | 2025-05-30 | Traditional | PDF ↗ |
| K243863 | Opulus Lymphoma Precision | Roche Molecular Systems, Inc. | 2025-05-30 | Traditional | PDF ↗ |
| K243378 | Rapid MLS | Ischemaview, Inc. | 2025-05-28 | Traditional | PDF ↗ |
| K250367 | CoLumboX | Smart Soft Healthcare AD | 2025-05-28 | Traditional | PDF ↗ |
| K250005 | Clever One | Ewoosoft Co., Ltd. | 2025-05-23 | Traditional | PDF ↗ |
| K243989 | Second Opinion® 3D | Pearl, Inc. | 2025-05-23 | Traditional | PDF ↗ |
| K243762 | Synapse 3D Base Tools (V7.0) | Fujifilm Corporation | 2025-05-21 | Traditional | PDF ↗ |
| K242624 | Medical Image Post-processing Software (uOmnispace.CT) | Shanghai United Imaging Healthcare Co., Ltd. | 2025-05-14 | Traditional | PDF ↗ |
| K243230 | Second Opinion® BLE | Pearl, Inc. | 2025-05-09 | Traditional | PDF ↗ |
| K250226 | Clarius Median Nerve AI | Clarius Mobile Health Corp. | 2025-05-08 | Traditional | PDF ↗ |
| K243684 | BrightHeart View Classifier | Brightheart | 2025-05-07 | Traditional | PDF ↗ |
| K250328 | UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program | Canon Medical Systems Corporation | 2025-04-30 | Traditional | PDF ↗ |
| K243853 | Clarius Prostate AI | Clarius Mobile Health Corp. | 2025-04-16 | Traditional | PDF ↗ |
| K242500 | LARALAB | Laralab GmbH | 2025-04-16 | Traditional | PDF ↗ |
| K250416 | GBrain MRI | Galileo Cds, Inc. | 2025-04-11 | Traditional | PDF ↗ |
| K250754 | cmAngio® (V1.6) | Curemetrix, Inc. | 2025-04-10 | Special | PDF ↗ |
| K241982 | DeepFoqus (DeepFoqus-Accelerate) | Foqus Technologies, Inc. | 2025-04-04 | Traditional | PDF ↗ |
| K242551 | syngo Dynamics (Version VA41D) | Siemens Healthcare GmbH | 2025-04-03 | Traditional | PDF ↗ |
| K241984 | Hi-D Imaging 4TAVR | Hi-D Imaging AG | 2025-04-02 | Traditional | PDF ↗ |
| K242166 | TribusConnect | Tribusmed Beheer BV | 2025-03-31 | Traditional | PDF ↗ |
| K243038 | Salix Central | Artrya Limited | 2025-03-27 | Traditional | PDF ↗ |
| K241961 | Vent Creativity Knee v1.0 (Hermes) | Vent Creativity | 2025-03-20 | Traditional | PDF ↗ |
| K250042 | PeekMed web | Peek Health, S.A. | 2025-03-19 | Traditional | PDF ↗ |
| K243689 | AVIEW | Coreline Soft Co., Ltd. | 2025-03-19 | Special | PDF ↗ |
| K243862 | LVivo Software Application | Dia Imaging Analysis, Ltd. | 2025-03-17 | Special | PDF ↗ |
| K242338 | Cleerly LABS (v2.0) | Cleerly, Inc. | 2025-03-07 | Special | PDF ↗ |
| K243331 | LVivo Seamless | Dia Imaging Analysis, Ltd. | 2025-03-06 | Special | PDF ↗ |
| K243933 | Ceevra Reveal 3+ | Ceevra, Inc. | 2025-03-04 | Traditional | PDF ↗ |
| K243235 | LVivo Software Application | Dia Imaging Analysis, Ltd. | 2025-03-03 | Traditional | PDF ↗ |
| K241922 | Myomics | Phantomics, Inc. | 2025-02-28 | Traditional | PDF ↗ |
| K241222 | Ventripoint Medical System Plus (VMS+) 4.0 | Ventripoint Diagnostics , Ltd. | 2025-02-26 | Traditional | PDF ↗ |
| K242607 | ScanDiags Ortho L-Spine MR-Q | Scandiags AG | 2025-02-21 | Traditional | PDF ↗ |
| K243696 | AVIEW CAC | Coreline Soft Co., Ltd. | 2025-02-14 | Special | PDF ↗ |
| K243250 | SubtleHD (1.x) | Subtle Medical, Inc. | 2025-02-12 | Traditional | PDF ↗ |
| K241659 | Ultrasound Workspace (UWS 6.0) | Philips Ultrasound, LLC | 2025-02-10 | Traditional | PDF ↗ |
| K241593 | BoneMetrics (US) | Gleamer Sas | 2025-02-05 | Traditional | PDF ↗ |
| K243158 | TeraRecon Aorta.CT (1.1.0) | Terarecon,Inc. | 2025-01-23 | Traditional | PDF ↗ |
| K243350 | Rapid Neuro3D | Ischemaview, Inc. | 2025-01-22 | Traditional | PDF ↗ |
| K241696 | Ortho AI | Ortho Ai, LLC | 2025-01-02 | Traditional | PDF ↗ |
| K242334 | Ezra Flash | Ezra Ai, Inc. | 2025-01-02 | Traditional | PDF ↗ |
| K243705 | Saige-Density (2.5.0) | DeepHealth, Inc. | 2024-12-19 | Special | PDF ↗ |
| K242270 | OrthoNext Platform System | Orthofix Srl | 2024-12-19 | Traditional | PDF ↗ |
| K240793 | MSKai | Mskai | 2024-12-16 | Traditional | PDF ↗ |
| K242461 | IRISeg | Intuitive Surgical, Inc. | 2024-12-10 | Traditional | PDF ↗ |
| K240680 | CDM Insights | Oxford Brain Diagnostics, Ltd. | 2024-12-06 | Traditional | PDF ↗ |
| K241543 | DrAid for Liver Segmentation | Vinbrain Joint Stock Company | 2024-12-06 | Traditional | PDF ↗ |
| K240645 | Sonix Health | Ontact Health Co., Ltd. | 2024-11-27 | Traditional | PDF ↗ |
| K242203 | BriefCase-Quantification | Aidoc Medical , Ltd. | 2024-11-22 | Traditional | PDF ↗ |
| K242359 | Strain AI (SAI001) | Exo, Inc. | 2024-11-20 | Traditional | PDF ↗ |
| K241312 | TeraRecon Cardiac.Chambers.MR (1.0.0) | Terarecon,Inc. | 2024-11-05 | Traditional | PDF ↗ |
| K241108 | RemedyLogic AI MRI Lumbar Spine Reader | Remedy Logic, Inc. | 2024-10-30 | Traditional | PDF ↗ |
| K243189 | TumorSight Viz | SimBioSys, Inc. | 2024-10-25 | Special | PDF ↗ |
| K242215 | Neurophet AQUA (V3.1) | Neurophet., Inc. | 2024-10-25 | Traditional | PDF ↗ |
| K242781 | cvi42 Software Application | Circle Cardiovascular Imaging, Inc. | 2024-10-15 | Special | PDF ↗ |
| K241430 | EchoMeasure | Icardio.Ai | 2024-10-10 | Traditional | PDF ↗ |
| K240786 | AutoChamber | HeartLung Corporation | 2024-10-10 | Traditional | PDF ↗ |
| K240553 | LVivo Software Application | Dia Imaging Analysis, Ltd. | 2024-10-04 | Special | PDF ↗ |
| K241561 | MammoScreen BD | Therapixel | 2024-10-02 | Traditional | PDF ↗ |
| K240943 | LungVision | Bodyvision Medical , Ltd. | 2024-10-01 | Traditional | PDF ↗ |
| K240036 | PIUR tUS Infinity | Piur Imaging GmbH | 2024-09-20 | Traditional | PDF ↗ |
| K241280 | Constellation (CON-001) | Q Bio, Inc. | 2024-09-12 | Traditional | PDF ↗ |
| K240094 | LumiNE US; Lumi | Augmedit B.V. | 2024-09-10 | Traditional | PDF ↗ |
| K241681 | Overjet Image Enhancement Assist | Overjet, Inc. | 2024-09-09 | Traditional | PDF ↗ |
| K240791 | ADAS 3D | Adas3D Medical S.L. | 2024-09-09 | Traditional | PDF ↗ |
| K240411 | uAI Portal | Shanghai United Imaging Intelligence Co., Ltd. | 2024-09-06 | Traditional | PDF ↗ |
| K242300 | MI View&GO | Siemens Medical Solutions USA, Inc. | 2024-08-30 | Special | PDF ↗ |
| K242275 | syngo.via MI Workflows; Scenium; syngo MBF | Siemens Medical Solutions USA, Inc. | 2024-08-30 | Special | PDF ↗ |
| K241847 | Imbio PHA (4.0.0) | Imbio, Inc. | 2024-08-30 | Special | PDF ↗ |
| K241684 | Overjet Charting Assist | Overjet, Inc. | 2024-08-27 | Traditional | PDF ↗ |
| K241098 | NeuroQuant | Cortechs Labs, Inc. | 2024-08-22 | Traditional | PDF ↗ |
| K240740 | qCT LN Quant | Qure.Ai Technologies | 2024-08-16 | Traditional | PDF ↗ |
| K241211 | CoLumbo | Smart Soft Healthcare | 2024-08-15 | Traditional | PDF ↗ |
Product code QIH · Class II · Radiology. Data: openFDA.