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)
Top companies in KPR
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 21, 2020 | K201670 | YSIO X.pree Siemens Medical Solutions USA, Inc. | KPR |
| Oct 7, 2020 | K202293 | Radiographic System Challenge X Sedecal., Sa., ES | KPR |
| Sep 24, 2020 | K202572 | GXR-Series Diagnostic X-Ray System DRGEM Corporation, KR | KPR |
| Sep 16, 2020 | K202394 | EOSedge Eos Imaging, FR | KPR |
| Sep 10, 2020 | K202156 | DIAMOND-5A/6A/8A DRGEM Corporation, KR | KPR |
| Jul 10, 2020 | K201725 | DigitalDiagnost C50 Philips Healthcare (Suzhou) Co., Lit., CN | KPR |
| Jul 9, 2020 | K201640 | DuraDiagnost Philips Healthcare (Suzhou) Co., Ltd., CN | KPR |
| Jun 26, 2020 | K201373 | DRX-Compass Carestream Health, Inc., CN | KPR |
| May 26, 2020 | K200944 | UNIEXPERT 2 PLUS Adani, BY | KPR |
| Mar 20, 2020 | K193089 | MULTIX Impact Siemens Medical Solutions USA, Inc. | KPR |
| Jan 28, 2020 | K193637 | MRH ALFA Radiographic System, MRH II Radiographic System, MRH IIE Radiographic System Compania Mexicana DE Radiologia Cgr, S.A. DE C.V., MX | KPR |
| Jan 22, 2020 | K193574 | Q-Rad System Carestream Health, Inc., CN | KPR |
| Jan 15, 2020 | K193225 | KDR AU-DDR System Advanced U-Arm with Dynamic Digital Radiography, KDR AU System Advanced U-Arm with Static Digital Radi Konica Minolta Healthcare Americas, Inc. | KPR |
| Jan 2, 2020 | K193360 | Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard Radmedix, LLC | KPR |
| Dec 20, 2019 | K191879 | DRX-Evolution with Carestream Digital Tomosynthesis Carestream Health, Inc. | KPR |
| Nov 27, 2019 | K192079 | EOSedge Eos Imaging, FR | KPR |
| Nov 4, 2019 | K190330 | DRX-Evolution/Plus with Dual Energy Carestream Health, Inc. | KPR |
| Oct 16, 2019 | K192541 | DigiX FDX Allengers Medical Systems Limited, IN | KPR |
| Oct 1, 2019 | K192453 | DIAMOND-5A/6A/8A DRGEM Corporation, KR | KPR |
| Sep 26, 2019 | K192364 | GXR-Series Diagnostic X-Ray System DRGEM Corporation, KR | KPR |
| Sep 12, 2019 | K192293 | uDR 592h, uDR 596i Shanghai United Imaging Healthcare Co., Ltd., CN | KPR |
| Jul 24, 2019 | K191699 | Discovery XR656 HD with VolumeRad Ge Hualun Medical Systems Co. , Ltd., CN | KPR |
| Jun 19, 2019 | K191418 | Multix Fusion Max Siemens Medical Solutions USA, Inc. | KPR |
| Apr 25, 2019 | K190601 | MasteRad MX30 Medicatech USA | KPR |
| Jan 24, 2019 | K183541 | ProRad 2FC and ProRad 3NC Stationary Radiographic Systems Prognosys Medical Systems Private Limited, IN | KPR |
| Jan 11, 2019 | K182517 | MULTIX Impact Siemens Medi Cal Solutions, Inc. | KPR |
| Dec 7, 2018 | K182183 | GC70, GU60A, GU60A-65, GF50, GR50A ; GR40CW ; GM85 ; GC85A Samsung Electronics Co., Ltd., KR | KPR |
| Nov 26, 2018 | K182134 | ARiX RAD Radiographic System Compania Mexicana DE Radiologia Cgr, S.A. DE C.V., MX | KPR |
| Oct 31, 2018 | K182880 | Halifax Imaging Kit Halifax Biomedical, Inc., CA | KPR |
| Oct 24, 2018 | K182647 | GC70 Samsung Electronics Co., Ltd., KR | KPR |
| Oct 23, 2018 | K182622 | GU60A, GU60A-65 Samsung Electronics Co., Ltd., KR | KPR |
| Jul 20, 2018 | K181629 | GC85A Samsung Electronics Co., Ltd., KR | KPR |
| Jun 27, 2018 | K181413 | uDR 592h, uDR 596i Shanghai United Imaging Healthcare Co., Ltd., CN | KPR |
| Jun 13, 2018 | K181279 | Ysio Max Siemens Medi Cal Solutions, Inc. | KPR |
| May 24, 2018 | K180543 | GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85 Samsung Electronics Co., Ltd., KR | KPR |
| May 18, 2018 | K180663 | LaVid FMTS DIAGNOSTIC X-RAY SYSTEM Livermoretech, Inc. | KPR |
| Apr 20, 2018 | K180765 | Televere Podiatry X-Ray System HF Televere Systems, Inc. | KPR |
| Mar 30, 2018 | K173517 | RADspeed fit Shimadzu Corporation, JP | KPR |
| Feb 9, 2018 | K173823 | Amrad Medical AAU Digital Radiography System; Amrad Medical AAU Plus Digital Radiography System; Amrad Medical DFMT Digi Summit Industries, LLC | KPR |
| Jan 26, 2018 | K173953 | uDR 780i Shanghai United Imaging Healthcare Co., Ltd., CN | KPR |
| Jan 12, 2018 | K173828 | GU60A & GU60A-65 Samsung Electronics Co., Ltd., KR | KPR |
| Dec 11, 2017 | K173612 | Optima XR646 HD Ge Hualun Medical Systems Co. , Ltd., CN | KPR |
| Nov 22, 2017 | K172229 | GC85A Samsung Electronics Co., Ltd., KR | KPR |
| Oct 20, 2017 | K172869 | Discovery XR656 HD Ge Hualun Medical Systems Co. , Ltd., CN | KPR |
| Mar 3, 2017 | K162529 | DigiX FDX Allengers Medical Systems Limited, IN | KPR |
| Feb 24, 2017 | K160857 | HF 718BD X-Ray System Arquilla, Inc. Dba X-Cel X-Ray Corporation | KPR |
| Jan 4, 2017 | K163410 | DigitalDiagnost C50 Philips Healthcare (Suzhou) Co., Ltd., CN | KPR |
| Dec 13, 2016 | K163203 | Carestream DRX-Evolution Carestream Health, Inc. | KPR |
| Dec 7, 2016 | K163115 | GC70 Samsung Electronics Co., Ltd., KR | KPR |
| Dec 2, 2016 | K152813 | FS-500DDR Medical Radiographic X-Ray System Orich Medical Equipment (Tianjin) Co., Ltd., CN | KPR |
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