510(k) Report

Devices descending from K093427

7 later devices reach FDR Acselerate System, DR-ID 200 Flat Panel Detector through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152294FDR Visionary SuiteShimadzu Corporation201615
+1K152244RADspeed ProShimadzu Corporation201632
+1K121499Fujifilm Tomosynthesis Option for FDR Acselerate Stationary X-Ray SystemFujifilm Medical System U.S.A., Inc.20126—
+2K233719FDR Visionary SuiteShimadzu Corporation20240—
+2K233722RADspeed ProShimadzu Corporation202401
+2K173517RADspeed fitShimadzu Corporation20181—
+3K220518Skanrad 400Skanray Technologies Limited20220—