ClearanceBrief
Panels › Radiology › Product code KPR · Class 2

System, X-Ray, Stationary

Regulation 892.1680

7510(k)s in 12 months (359 all time)
3recalls in 12 months (170 all time)
160recalls that name a 510(k)
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Top companies in KPR

Company510(k)sRecalls
Siemens Medical Solutions1731
Carestream Health1111
Samsung Electronics Co., Ltd.210
GE Healthcare119
GE Medical Systems99
Imaging Dynamics Company , Ltd.110
Philips Medical Systems North America Co. Phillips011
Philips Healthcare010
Philips Medical Systems (Cleveland), Inc.81
Philips Medical Systems Dmc GmbH36
Decided510(k)Device and applicantCode
Sep 8, 2026K260227EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50H
DRTECH Corporation, KR
KPR
Aug 31, 2026K260488MULTIX Impact; MULTIX Impact C
Siemens Medical Solutions USA, Inc.
KPR
Aug 27, 2026K260481GC85A
Samsung Electronics Co., Ltd., KR
KPR
Jun 15, 2026K260482DRE Duo
Jpi Healthcare Co, Ltd., KR
KPR
Apr 10, 2026K253446AeroDR TX c02
Dk Medical Systems Co., Ltd., KR
KPR
Jan 20, 2026K250954DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detector
Carestream Health
KPR
Nov 26, 2025K252000uDR Arria & uDR Aris
Shanghai United Imaging Healthcare Co., Ltd., CN
KPR
Sep 19, 2025K251167uDR Aurora CX
Shanghai United Imaging Healthcare Co., Ltd., CN
KPR
Aug 28, 2025K250788Definium Tempo Select
Ge Hualun Medical Systems Co. , Ltd., CN
KPR
Aug 1, 2025K250790INNOVISION-DXII
Dk Medical Systems Co., Ltd., KR
KPR
Jul 31, 2025K250738YSIO X.pree
Siemens Medical Solutions
KPR
Jan 7, 2025K242019GXR-Series Diagnostic X-Ray System
DRGEM Corporation, KR
KPR
Jan 6, 2025K242499Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E))
Shenzhen Sontu Medical Imaging Equipment Co., Ltd., CN
KPR
Jan 3, 2025K242119INNOVISION-EXII
Dk Medical System, KR
KPR
Nov 1, 2024K241068uDR 780i
Shanghai United Imaging Healthcare Co., Ltd., CN
KPR
Oct 23, 2024K242847EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS DEXi-D402S-FRM); EXSYS DEXi (EXS
DRTECH Corporation, KR
KPR
Oct 1, 2024K242678Definium Pace Select ET
Ge Hualun Medical Systems Co. , Ltd., CN
KPR
Sep 19, 2024K242478GF85 (models GF85-3P, GF85-SP)
Samsung Electronics Co., Ltd., KR
KPR
Aug 6, 2024K233920EOSedge
Eos Imaging, FR
KPR
Jul 26, 2024K233530EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS DEXi-D402S-FRM); EXSYS DEXi (EXS
DRTECH Corporation, KR
KPR
Jun 13, 2024K233662Radiography 7300 C
Philips Medical Systems Dmc GmbH, DE
KPR
May 21, 2024K233543YSIO X.pree
Siemens Medical Solutions
KPR
Mar 28, 2024K233719FDR Visionary Suite
Shimadzu Corporation, JP
KPR
Mar 12, 2024K233381DRX-Evolution Plus System
Carestream Health, Inc.
KPR
Feb 23, 2024K233722RADspeed Pro
Shimadzu Corporation, JP
KPR
Nov 29, 2023K233532MULTIX Impact E
Siemens Medical Solutions
KPR
Nov 2, 2023K230800XVISION-525, HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F PF50
GEMSS HEALTHCARE CO., LTD., KR
KPR
Oct 27, 2023K231761PodSKAN HF Diagnostic X-ray System
Skanray Technologies Limited, IN
KPR
Oct 25, 2023K231995AcuityUDR
Radmedix, LLC
KPR
Sep 19, 2023K232178GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series)
DRGEM Corporation, KR
KPR
Sep 12, 2023K231892Definium Pace Select
Ge Hualun Medical Systems Co. , Ltd., CN
KPR
Apr 10, 2023K223550DMX
Del Medical, Inc.
KPR
Feb 23, 2023K230241Jumong General
Sg Healthcare Co, Ltd., KR
KPR
Jan 20, 2023K223842DRX - Compass
Carestream Health, Inc., CN
KPR
Oct 26, 2022K223060DigiX FDX
Allengers Medical Systems Limited, IN
KPR
Jul 27, 2022K221853OTC DDR
Konica Minolta Healthcare Americas, Inc.
KPR
May 17, 2022K220919MULTIX Impact E
Siemens Medical Solutions USA, Inc.
KPR
Apr 29, 2022K220271Hand Diagnostic Radiography Imaging System
Nanoray Biotech Co., Ltd., TW
KPR
Apr 19, 2022K220149General Radiography X-ray System (Model: GR10X 40K), General Radiography X-ray System (Model: GR10X 50K)
Xera Medical Systems & Technology , Ltd., TR
KPR
Apr 1, 2022K220518SKANRAD 400
Skanray Technologies Limited, IN
KPR
Feb 18, 2022K213057ExamVue Duo
Jpi Healthcare Co, Ltd., KR
KPR
Jan 12, 2022K214012Straight Arm DDR
Konica Minolta Healthcare Americas, Inc.
KPR
Dec 13, 2021K213700MULTIX Impact, MULTIX Impact C
Siemens Medical Solutions USA, Inc.
KPR
Dec 13, 2021K212186Philips Radiology Smart Assistant
Philips Medical Systems Dmc GmbH, DE
KPR
Apr 2, 2021K210692DigitalDiagnost
Philips Medical Systems Dmc GmbH, DE
KPR
Feb 1, 2021K203537Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic Systems
Sedecal., Sa., ES
KPR
Jan 7, 2021K203345MULTIX Impact
Siemens Medical Solutions USA, Inc.
KPR
Jan 6, 2021K203340MULTIX Impact C
Siemens Medical Solutions USA, Inc.
KPR
Dec 1, 2020K202388Apolo D / Apolo S
Vmi Tecnologias Ltda, BR
KPR
Nov 20, 2020K201825MiniCAT 2D
Xoran Technologies, LLC
KPR

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