510(k) Report

Devices descending from K201528

7 later devices reach Yushan X-Ray Flat Panel Detector with DROC through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250211Yushan X-Ray Flat Panel DetectorInnocare Optoelectronics Corp.20250—
+1K243171Yushan X-Ray Flat Panel DetectorInnocare Optoelectronics Corp.20241—
+1K240771PRORAD X-Ray Flat Panel Detector with DROCPrognosys Medical Systems Private Limited20240—
+1K223009Wireless/Wired X-Ray Flat Panel DetectorsAllengers Medical Systems Limited20221—
+1K220510Yushan X-Ray Flat Panel Detector with DROCInnocare Optoelectronics Corp.20225—
+1K210988Yushan X-Ray Flat Panel Detector with DROCInnocare Optoelectronics Corp.20215—
+2K243734Wireless/ Wired X-Ray Flat Panel DetectorsAllengers Medical Systems Limited20250—