510(k) Report

Devices descending from K012389

103 later devices reach Revolution XR/D Digital Radiographic Imaging System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K252649TAP2DNano-X Imaging, Ltd.20260—
+8K251443PROMODRGEM Corporation20250—
+8K241346IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector)Aspen Imaging Healthcare, Inc.20240—