510(k) Report

Devices descending from K012086

207 later devices reach Aquariusnet Server through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K240793MSKaiMskai20240—
+10K240680CDM InsightsOxford Brain Diagnostics, Ltd.20240—
+10K241108RemedyLogic AI MRI Lumbar Spine ReaderRemedy Logic, Inc.20240—
+10K232305AI-Rad Companion Brain MRSiemens Medical Solutions U.S.A.20231—
+10K212321JiveX (Model Number / Release: 5.3)Visus Health IT GmbH20211—
+11K253057AI-Rad Companion Brain MRSiemens Healthcare GmbH20260—
+11K231041JiveX (Model Number / Release: 5.4)Visus Health IT GmbH20230—