510(k) Report

Devices descending from K102408

17 later devices reach Digital Diagnostic X-Ray System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192453Diamond-5A/6A/8ADRGEM Corporation20192—
+1K192364GXR-Series Diagnostic X-Ray SystemDRGEM Corporation201911—
+1K132921Galaxy PlusMedien International Co, Ltd.20140—
+1K123105Xgeo GU60Samsung Electronics Co., Ltd.20130—
+2K260482DRE DuoJpi Healthcare Co, Ltd.20260—
+2K230800Xvision-525, Horizon, HI-300, HI-500, Saturn-F PF32, Saturn-F PF40, Saturn-F PF50Gemss Healthcare CO., LTD.20230—
+2K202572GXR-Series Diagnostic X-Ray SystemDRGEM Corporation20208—
+2K202156Diamond-5A/6A/8ADRGEM Corporation20201—
+3K242019GXR-Series Diagnostic X-Ray SystemDRGEM Corporation20250—
+3K242119Innovision-ExiiDk Medical System20252—
+3K233530EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS…DRTECH Corporation20242—
+3K232178GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series)DRGEM Corporation20230—
+3K220271Hand Diagnostic Radiography Imaging SystemNanoray Biotech Co., Ltd.20220—
+4K253446AeroDR TX c02Dk Medical Systems Co., Ltd.20260—
+4K250790Innovision-DxiiDk Medical Systems Co., Ltd.20250—
+4K242847EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS…DRTECH Corporation20241—
+5K260227EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS…DRTECH Corporation20260—