510(k) Report

Devices descending from K994329

208 later devices reach Iivs Integrated Image Viewing Station through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K242607ScanDiags Ortho L-Spine MR-QScandiags AG20250—
+11K240793MSKaiMskai20240—
+11K240680CDM InsightsOxford Brain Diagnostics, Ltd.20240—
+11K241108RemedyLogic AI MRI Lumbar Spine ReaderRemedy Logic, Inc.20240—
+11K232305AI-Rad Companion Brain MRSiemens Medical Solutions U.S.A.20231—
+11K212321JiveX (Model Number / Release: 5.3)Visus Health IT GmbH20211—
+12K253057AI-Rad Companion Brain MRSiemens Healthcare GmbH20260—
+12K231041JiveX (Model Number / Release: 5.4)Visus Health IT GmbH20230—