510(k) Report

Devices descending from K213497

2 later devices reach ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223930A1417MCW/A1717MCW/F1417MCWH&abyz Co., Ltd.20231—
+2K241346IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector)Aspen Imaging Healthcare, Inc.20240—