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KPR — System, X-Ray, Stationary Class II

FDA Device Classification

Classification Details

Product Code
KPR
Device Class
Class II
Regulation Number
892.1680
Submission Type
Review Panel
RA
Medical Specialty
Radiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K250954carestream healthDRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 deteJanuary 20, 2026
K252000shanghai united imaging healthcare couDR Arria & uDR ArisNovember 26, 2025
K251167shanghai united imaging healthcare couDR Aurora CXSeptember 19, 2025
K250788ge hualun medical systems co.Definium Tempo SelectAugust 28, 2025
K250790dk medical systems coINNOVISION-DXIIAugust 1, 2025
K250738siemens medical solutionsYSIO X.preeJuly 31, 2025
K242019drgem corporationGXR-Series Diagnostic X-Ray SystemJanuary 7, 2025
K242499shenzhen sontu medical imaging equipment coDigital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E))January 6, 2025
K242119dk medical systemINNOVISION-EXIIJanuary 3, 2025
K241068shanghai united imaging healthcare couDR 780iNovember 1, 2024
K242847drtech corporationEXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXiOctober 23, 2024
K242678ge hualun medical systems co.Definium Pace Select ETOctober 1, 2024
K242478samsung electronics coGF85 (models GF85-3P, GF85-SP)September 19, 2024
K233920eos imagingEOSedgeAugust 6, 2024
K233530drtech corporationEXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXiJuly 26, 2024
K233662philips medical systems dmcRadiography 7300 CJune 13, 2024
K233543siemens medical solutionsYSIO X.preeMay 21, 2024
K233719shimadzu corporationFDR Visionary SuiteMarch 28, 2024
K233381carestream healthDRX-Evolution Plus SystemMarch 12, 2024
K233722shimadzu corporationRADspeed ProFebruary 23, 2024