510(k) Report

Devices descending from K132261

21 later devices reach Discovery XR656 with Volumerad (Digital Tomosynthesis) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191699Discovery XR656 HD with VolumeRadGe Hualun Medical Systems Co., Ltd.201913
+1K183275DR 800 with TomosynthesisAgfa N.V.201983
+1K142341X-Ray TV System Sonialvision G4Shimadzu Corp.201552
+1K143270Optima XR646Ge Hualun Medical Systems Co., Ltd.20156—
+2K250788Definium Tempo SelectGe Hualun Medical Systems Co., Ltd.20250—
+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—
+2K190373SonialVision G4Shimadzu Corporation201942
+2K172869Discovery XR656 HDGe Hualun Medical Systems Co., Ltd.201751
+3K252133Adaptix Ortho350Adaptix Limited20250—
+3K231892Definium Pace SelectGe Hualun Medical Systems Co., Ltd.202311
+3K222934Nanox.ARCNano-X Imaging, Ltd.20233—
+3K212212Multitom Rax with True2scale Body Scan OptionSiemens Medical Solutions20221—
+3K191877FLUOROspeedShimadzu Corporation201902
+3K173612Optima XR646 HDGe Hualun Medical Systems Co., Ltd.201701
+4K242395Nanox.ARCNano-X Imaging, Ltd.20242—
+4K242678Definium Pace Select ETGe Hualun Medical Systems Co., Ltd.20240—
+4K221281Multitom RaxSiemens Medical Solutions202201
+5K250850Nanox.ARC XNano-X Imaging, Ltd.20251—
+6K252649TAP2DNano-X Imaging, Ltd.20260—