510(k) Report

Devices descending from K944967

30 later devices reach Tomo-Link through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K051967Revolution XR/D Digital Radiographic Imaging System with TomosynthesisGE Healthcare2005299
+2K132261Discovery XR656 with Volumerad (Digital Tomosynthesis)Ge Medical Systems, LLC2013211
+2K121499Fujifilm Tomosynthesis Option for FDR Acselerate Stationary X-Ray SystemFujifilm Medical System U.S.A., Inc.20126—
+3K191699Discovery XR656 HD with VolumeRadGe Hualun Medical Systems Co., Ltd.201913
+3K183275DR 800 with TomosynthesisAgfa N.V.201983
+3K152294FDR Visionary SuiteShimadzu Corporation201615
+3K152244RADspeed ProShimadzu Corporation201632
+3K142341X-Ray TV System Sonialvision G4Shimadzu Corp.201552
+3K143270Optima XR646Ge Hualun Medical Systems Co., Ltd.20156—
+4K250788Definium Tempo SelectGe Hualun Medical Systems Co., Ltd.20250—
+4K233719FDR Visionary SuiteShimadzu Corporation20240—
+4K233722RADspeed ProShimadzu Corporation202401
+4K221949Ortho Device, ADAPTIX 3D Orthopedic Imaging SystemPausch Medical GmbH20231—
+4K212145DR 800 with DSA, DR 800Agfa N.V.20210—
+4K193262DR 600 with TomosynthesisAgfa N.V.20204—
+4K190373SonialVision G4Shimadzu Corporation201942
+4K173517RADspeed fitShimadzu Corporation20181—
+4K172869Discovery XR656 HDGe Hualun Medical Systems Co., Ltd.201751
+5K252133Adaptix Ortho350Adaptix Limited20250—
+5K231892Definium Pace SelectGe Hualun Medical Systems Co., Ltd.202311
+5K222934Nanox.ARCNano-X Imaging, Ltd.20233—
+5K220518Skanrad 400Skanray Technologies Limited20220—
+5K212212Multitom Rax with True2scale Body Scan OptionSiemens Medical Solutions20221—
+5K191877FLUOROspeedShimadzu Corporation201902
+5K173612Optima XR646 HDGe Hualun Medical Systems Co., Ltd.201701
+6K242395Nanox.ARCNano-X Imaging, Ltd.20242—
+6K242678Definium Pace Select ETGe Hualun Medical Systems Co., Ltd.20240—
+6K221281Multitom RaxSiemens Medical Solutions202201
+7K250850Nanox.ARC XNano-X Imaging, Ltd.20251—
+8K252649TAP2DNano-X Imaging, Ltd.20260—