510(k) Report

Devices descending from K101686

7 later devices reach FDR Image Stitching Option through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152294FDR Visionary SuiteShimadzu Corporation201615
+1K152244RADspeed ProShimadzu Corporation201632
+1K152138FDR D-EVO GL Flat Panel Detector SystemFujifilm Medical System U.S.A., Inc.20150—
+2K233719FDR Visionary SuiteShimadzu Corporation20240—
+2K233722RADspeed ProShimadzu Corporation202401
+2K173517RADspeed fitShimadzu Corporation20181—
+3K220518Skanrad 400Skanray Technologies Limited20220—