510(k) Report

Devices descending from K183275

8 later devices reach DR 800 with Tomosynthesis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221949Ortho Device, ADAPTIX 3D Orthopedic Imaging SystemPausch Medical GmbH20231—
+1K212145DR 800 with DSA, DR 800Agfa N.V.20210—
+1K193262DR 600 with TomosynthesisAgfa N.V.20204—
+2K252133Adaptix Ortho350Adaptix Limited20250—
+2K222934Nanox.ARCNano-X Imaging, Ltd.20233—
+3K242395Nanox.ARCNano-X Imaging, Ltd.20242—
+4K250850Nanox.ARC XNano-X Imaging, Ltd.20251—
+5K252649TAP2DNano-X Imaging, Ltd.20260—