510(k) Report

Devices descending from K140380

10 later devices reach Opera Swing through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180589DR 800 with MUSICA DynamicAgfa Healthcare N.V.201893
+2K183275DR 800 with TomosynthesisAgfa N.V.201983
+3K221949Ortho Device, ADAPTIX 3D Orthopedic Imaging SystemPausch Medical GmbH20231—
+3K212145DR 800 with DSA, DR 800Agfa N.V.20210—
+3K193262DR 600 with TomosynthesisAgfa N.V.20204—
+4K252133Adaptix Ortho350Adaptix Limited20250—
+4K222934Nanox.ARCNano-X Imaging, Ltd.20233—
+5K242395Nanox.ARCNano-X Imaging, Ltd.20242—
+6K250850Nanox.ARC XNano-X Imaging, Ltd.20251—
+7K252649TAP2DNano-X Imaging, Ltd.20260—