510(k) Report

Devices descending from K193262

4 later devices reach DR 600 with Tomosynthesis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222934Nanox.ARCNano-X Imaging, Ltd.20233—
+2K242395Nanox.ARCNano-X Imaging, Ltd.20242—
+3K250850Nanox.ARC XNano-X Imaging, Ltd.20251—
+4K252649TAP2DNano-X Imaging, Ltd.20260—