510(k) Report

Devices descending from K862120

227 later devices reach SCX System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K221281Multitom RaxSiemens Medical Solutions202201
+9K222353GM85Samsung Electronics Co., Ltd.202223
+9K21404414HQ901G-BLg Electronics.Inc20221—
+9K212269Intelligent NRCanon, Inc.20210—
+9K2121056543Z, 4386Z, 4343Z, 4343ZF, 3543Z, 3543ZF, 3030Z, 3025Z, 3025ZFPzmedical Technology Co., Ltd.20210—
+9K2109851717FCCRayence Co., Ltd.20210—
+9K202564DigitalDiagnost C90Philips Medical Systems Dmc GmbH202028
+9K201124TOPAZ Mobile DR SystemDRGEM Corporation20203—
+9K193173CareView 1800LeCareray Digital Medical System Co., Ltd.20194—
+9K181629GC85ASamsung Electronics Co., Ltd.20185—
+9K173828GU60A & GU60A-65Samsung Electronics Co., Ltd.201819—
+10K260481GC85ASamsung Electronics Co., Ltd.20260—
+10K250850Nanox.ARC XNano-X Imaging, Ltd.20251—
+10K242015TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D)DRGEM Corporation20242—
+10K241346IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector)Aspen Imaging Healthcare, Inc.20240—
+10K242651GM85Samsung Electronics Co., Ltd.20240—
+10K242478GF85 (models GF85-3P, GF85-SP)Samsung Electronics Co., Ltd.20240—
+10K221549X-ray Flat Panel Detectors (CareView 1800 RF)Careray Digital Medical Technology Co., Ltd.20222—
+10K22055917HQ901G-BLg Electronics.Inc20220—
+10K210692DigitalDiagnostPhilips Medical Systems Dmc GmbH202118
+10K201932X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe)Careray Digital Medical System Co., Ltd.20200—
+11K260085RAYMO Mobile X-ray System (Model: RAYMO)DRGEM Corporation20260—
+11K252649TAP2DNano-X Imaging, Ltd.20260—
+11K251443PROMODRGEM Corporation20250—
+11K223687X-ray Flat Panel Detectors (EverestView 4343X)Careray Digital Medical Technology Co., Ltd.20221—
+11K212186Philips Radiology Smart AssistantPhilips Medical Systems Dmc GmbH20210—
+12K232058YosemiteView 4343W/YosemiteView 3643WCareray Digital Medical Technology Co., Ltd.20230—