510(k) Report

Devices descending from K982196

221 later devices reach Digital Radiographic Imaging System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K202564DigitalDiagnost C90Philips Medical Systems Dmc GmbH202028
+8K201124TOPAZ Mobile DR SystemDRGEM Corporation20203—
+8K193173CareView 1800LeCareray Digital Medical System Co., Ltd.20194—
+8K181629GC85ASamsung Electronics Co., Ltd.20185—
+8K173828GU60A & GU60A-65Samsung Electronics Co., Ltd.201819—
+9K260481GC85ASamsung Electronics Co., Ltd.20260—
+9K250850Nanox.ARC XNano-X Imaging, Ltd.20251—
+9K242015TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D)DRGEM Corporation20242—
+9K241346IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector)Aspen Imaging Healthcare, Inc.20240—
+9K242651GM85Samsung Electronics Co., Ltd.20240—
+9K242478GF85 (models GF85-3P, GF85-SP)Samsung Electronics Co., Ltd.20240—
+9K221549X-ray Flat Panel Detectors (CareView 1800 RF)Careray Digital Medical Technology Co., Ltd.20222—
+9K22055917HQ901G-BLg Electronics.Inc20220—
+9K210692DigitalDiagnostPhilips Medical Systems Dmc GmbH202118
+9K201932X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe)Careray Digital Medical System Co., Ltd.20200—
+10K260085RAYMO Mobile X-ray System (Model: RAYMO)DRGEM Corporation20260—
+10K252649TAP2DNano-X Imaging, Ltd.20260—
+10K251443PROMODRGEM Corporation20250—
+10K223687X-ray Flat Panel Detectors (EverestView 4343X)Careray Digital Medical Technology Co., Ltd.20221—
+10K212186Philips Radiology Smart AssistantPhilips Medical Systems Dmc GmbH20210—
+11K232058YosemiteView 4343W/YosemiteView 3643WCareray Digital Medical Technology Co., Ltd.20230—