510(k) Report

Devices descending from K180589

9 later devices reach DR 800 with MUSICA Dynamic through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K183275DR 800 with TomosynthesisAgfa N.V.201983
+2K221949Ortho Device, ADAPTIX 3D Orthopedic Imaging SystemPausch Medical GmbH20231—
+2K212145DR 800 with DSA, DR 800Agfa N.V.20210—
+2K193262DR 600 with TomosynthesisAgfa N.V.20204—
+3K252133Adaptix Ortho350Adaptix Limited20250—
+3K222934Nanox.ARCNano-X Imaging, Ltd.20233—
+4K242395Nanox.ARCNano-X Imaging, Ltd.20242—
+5K250850Nanox.ARC XNano-X Imaging, Ltd.20251—
+6K252649TAP2DNano-X Imaging, Ltd.20260—