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Panels › Radiology › Product code QIH · Class 2

Automated Radiological Image Processing Software

Regulation 892.2050

91510(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
DateFirm and productCodeLinked 510(k)
Jul 21, 2026PIE Medical Imaging B.V.
3mensio Workstation (Vascular Fenestrated) software
Open, Classified		 QIHK250330
May 19, 2021Caption Health
Version: 1.2.0 (1.2.0+85ela410) Caption Health, Caption AI, Ultrasound Imaging System Application Software (GMDN: 40873), UDI: (01)00860003586303(10)1.2.0)
Terminated		 QIHK200621

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