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Panels › Radiology › Product code QIH · Class 2

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)
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Top companies in QIH

Company510(k)sRecalls
Siemens Medical Solutions U.S.A.140
Dia Imaging Analysis, Ltd.100
Ischemaview, Inc.60
Shanghai United Imaging Healthcare Co., Ltd.60
Clarius Mobile Health Corp.50
Overjet, Inc.50
Siemens Healthcare GmbH50
Aidoc Medical , Ltd.40
Ceevra, Inc.40
Circle Cardiovascular Imaging40
Decided510(k)Device and applicantCode
Apr 2, 2025K241984Hi-D Imaging 4TAVR
Hi-D Imaging AG, CH
QIH
Mar 31, 2025K242166TribusConnect
Tribusmed Beheer BV, NL
QIH
Mar 27, 2025K243038Salix Central
Artrya Limited, AU
QIH
Mar 20, 2025K241961Vent Creativity Knee v1.0 (Hermes)
Vent Creativity
QIH
Mar 19, 2025K250042PeekMed web
Peek Health, S.A., PT
QIH
Mar 19, 2025K243689AVIEW
Coreline Soft Co., Ltd., KR
QIH
Mar 17, 2025K243862LVivo Software Application
Dia Imaging Analysis, Ltd., IL
QIH
Mar 7, 2025K242338Cleerly LABS (v2.0)
Cleerly, Inc.
QIH
Mar 6, 2025K243331LVivo Seamless
Dia Imaging Analysis, Ltd., IL
QIH
Mar 4, 2025K243933Ceevra Reveal 3+
Ceevra, Inc.
QIH
Mar 3, 2025K243235LVivo Software Application
Dia Imaging Analysis, Ltd., IL
QIH
Feb 28, 2025K241922Myomics
Phantomics, Inc., KR
QIH
Feb 26, 2025K241222Ventripoint Medical System Plus (VMS+) 4.0
Ventripoint Diagnostics , Ltd., CA
QIH
Feb 21, 2025K242607ScanDiags Ortho L-Spine MR-Q
Scandiags AG, CH
QIH
Feb 14, 2025K243696AVIEW CAC
Coreline Soft Co., Ltd., KR
QIH
Feb 12, 2025K243250SubtleHD (1.x)
Subtle Medical, Inc.
QIH
Feb 10, 2025K241659Ultrasound Workspace (UWS 6.0)
Philips Ultrasound, LLC
QIH
Feb 5, 2025K241593BoneMetrics (US)
Gleamer Sas, FR
QIH
Jan 23, 2025K243158TeraRecon Aorta.CT (1.1.0)
Terarecon,Inc.
QIH
Jan 22, 2025K243350Rapid Neuro3D
Ischemaview, Inc.
QIH
Jan 2, 2025K242334Ezra Flash
Ezra Ai, Inc.
QIH
Jan 2, 2025K241696Ortho AI
Ortho Ai, LLC
QIH
Dec 19, 2024K243705Saige-Density (2.5.0)
DeepHealth, Inc.
QIH
Dec 19, 2024K242270OrthoNext Platform System
Orthofix Srl, IT
QIH
Dec 16, 2024K240793MSKai
Mskai
QIH
Dec 10, 2024K242461IRISeg
Intuitive Surgical, Inc.
QIH
Dec 6, 2024K241543DrAid™ for Liver Segmentation
Vinbrain Joint Stock Company, VN
QIH
Dec 6, 2024K240680CDM Insights
Oxford Brain Diagnostics, Ltd., GB
QIH
Nov 27, 2024K240645Sonix Health
Ontact Health Co., Ltd., KR
QIH
Nov 22, 2024K242203BriefCase-Quantification
Aidoc Medical , Ltd., IL
QIH
Nov 20, 2024K242359Strain AI (SAI001)
Exo, Inc.
QIH
Nov 5, 2024K241312TeraRecon Cardiac.Chambers.MR (1.0.0)
Terarecon,Inc.
QIH
Oct 30, 2024K241108RemedyLogic AI MRI Lumbar Spine Reader
Remedy Logic, Inc.
QIH
Oct 25, 2024K243189TumorSight Viz
SimBioSys, Inc.
QIH
Oct 25, 2024K242215Neurophet AQUA (V3.1)
Neurophet., Inc., KR
QIH
Oct 15, 2024K242781cvi42 Software Application
Circle Cardiovascular Imaging, Inc., CA
QIH
Oct 10, 2024K241430EchoMeasure
Icardio.Ai
QIH
Oct 10, 2024K240786AutoChamber
HeartLung Corporation
QIH
Oct 4, 2024K240553LVivo Software Application
Dia Imaging Analysis, Ltd., IL
QIH
Oct 2, 2024K241561MammoScreen BD
Therapixel, FR
QIH
Oct 1, 2024K240943LungVision
Bodyvision Medical , Ltd., IL
QIH
Sep 20, 2024K240036PIUR tUS Infinity
Piur Imaging GmbH, AT
QIH
Sep 12, 2024K241280Constellation (CON-001)
Q Bio, Inc.
QIH
Sep 10, 2024K240094LumiNE US; Lumi
Augmedit B.V., NL
QIH
Sep 9, 2024K241681Overjet Image Enhancement Assist
Overjet, Inc.
QIH
Sep 9, 2024K240791ADAS 3D
Adas3D Medical S.L., ES
QIH
Sep 6, 2024K240411uAI Portal
Shanghai United Imaging Intelligence Co., Ltd., CN
QIH
Aug 30, 2024K242300MI View&GO
Siemens Medical Solutions USA, Inc.
QIH
Aug 30, 2024K242275syngo.via MI Workflows; Scenium; syngo MBF
Siemens Medical Solutions USA, Inc.
QIH
Aug 30, 2024K241847Imbio PHA (4.0.0)
Imbio, Inc.
QIH

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