FDA Product Code
FDA Product Code KPR — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.1680
510(k) Clearances — 359 records · page 1 of 4
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260227 | EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50H | DRTECH Corporation | 2026-09-08 | Traditional | PDF ↗ |
| K260488 | MULTIX Impact; MULTIX Impact C | Siemens Medical Solutions USA, Inc. | 2026-08-31 | Traditional | PDF ↗ |
| K260481 | GC85A | Samsung Electronics Co., Ltd. | 2026-08-27 | Traditional | PDF ↗ |
| K260482 | DRE Duo | Jpi Healthcare Co, Ltd. | 2026-06-15 | Traditional | PDF ↗ |
| K253446 | AeroDR TX c02 | Dk Medical Systems Co., Ltd. | 2026-04-10 | Traditional | PDF ↗ |
| K250954 | DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detector | Carestream Health | 2026-01-20 | Traditional | PDF ↗ |
| K252000 | uDR Arria & uDR Aris | Shanghai United Imaging Healthcare Co., Ltd. | 2025-11-26 | Traditional | PDF ↗ |
| K251167 | uDR Aurora CX | Shanghai United Imaging Healthcare Co., Ltd. | 2025-09-19 | Traditional | PDF ↗ |
| K250788 | Definium Tempo Select | Ge Hualun Medical Systems Co. , Ltd. | 2025-08-28 | Traditional | PDF ↗ |
| K250790 | INNOVISION-DXII | Dk Medical Systems Co., Ltd. | 2025-08-01 | Traditional | PDF ↗ |
| K250738 | YSIO X.pree | Siemens Medical Solutions | 2025-07-31 | Traditional | PDF ↗ |
| K242019 | GXR-Series Diagnostic X-Ray System | DRGEM Corporation | 2025-01-07 | Traditional | PDF ↗ |
| K242499 | Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E)) | Shenzhen Sontu Medical Imaging Equipment Co., Ltd. | 2025-01-06 | Traditional | PDF ↗ |
| K242119 | INNOVISION-EXII | Dk Medical System | 2025-01-03 | Traditional | PDF ↗ |
| K241068 | uDR 780i | Shanghai United Imaging Healthcare Co., Ltd. | 2024-11-01 | Traditional | PDF ↗ |
| K242847 | EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS DEXi-D402S-FRM); EXSYS DEXi (EXSYS DEXi-A402S-FRM); EXSYS DEXi (EXSYS DEXi-D401P-FRM); EXSYS DEXi (EXSYS DEXi-A401P-FRM); EXSYS DEXi (EXSYS DEXi-D402P-FRM); EXSYS DEXi (EXSYS DEXi-A402P-FRM); EXSYS DEXi (EXSYS DEXi-D503T-FRM); EXSYS DEXi (EXSYS DEXi-A503T-FRM); EXSYS DEXi (EXSYS DEXi-D401S-FRA); EXSYS DEXi (EXSYS DEXi-D402S-FRA); EXSYS DEXi (EXSYS DEXi-D401P-FRA); EXSYS DEXi (EXSYS DEXi-D402P-FRA); | DRTECH Corporation | 2024-10-23 | Special | PDF ↗ |
| K242678 | Definium Pace Select ET | Ge Hualun Medical Systems Co. , Ltd. | 2024-10-01 | Special | PDF ↗ |
| K242478 | GF85 (models GF85-3P, GF85-SP) | Samsung Electronics Co., Ltd. | 2024-09-19 | Traditional | PDF ↗ |
| K233920 | EOSedge | Eos Imaging | 2024-08-06 | Traditional | PDF ↗ |
| K233530 | EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS DEXi-D402S-FRM); EXSYS DEXi (EXSYS DEXi-A402S-FRM); EXSYS DEXi (EXSYS DEXi-D401P-FRM); EXSYS DEXi (EXSYS DEXi-A401P-FRM); EXSYS DEXi (EXSYS DEXi-D402P-FRM); EXSYS DEXi (EXSYS DEXi-A402P-FRM); EXSYS DEXi (EXSYS DEXi-D503T-FRM); EXSYS DEXi (EXSYS DEXi-A503T-FRM) | DRTECH Corporation | 2024-07-26 | Traditional | PDF ↗ |
| K233662 | Radiography 7300 C | Philips Medical Systems Dmc GmbH | 2024-06-13 | Traditional | PDF ↗ |
| K233543 | YSIO X.pree | Siemens Medical Solutions | 2024-05-21 | Traditional | PDF ↗ |
| K233719 | FDR Visionary Suite | Shimadzu Corporation | 2024-03-28 | Traditional | PDF ↗ |
| K233381 | DRX-Evolution Plus System | Carestream Health, Inc. | 2024-03-12 | Traditional | PDF ↗ |
| K233722 | RADspeed Pro | Shimadzu Corporation | 2024-02-23 | Traditional | PDF ↗ |
| K233532 | MULTIX Impact E | Siemens Medical Solutions | 2023-11-29 | Special | PDF ↗ |
| K230800 | XVISION-525, HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F PF50 | GEMSS HEALTHCARE CO., LTD. | 2023-11-02 | Traditional | PDF ↗ |
| K231761 | PodSKAN HF Diagnostic X-ray System | Skanray Technologies Limited | 2023-10-27 | Traditional | PDF ↗ |
| K231995 | AcuityUDR | Radmedix, LLC | 2023-10-25 | Abbreviated | PDF ↗ |
| K232178 | GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series) | DRGEM Corporation | 2023-09-19 | Traditional | PDF ↗ |
| K231892 | Definium Pace Select | Ge Hualun Medical Systems Co. , Ltd. | 2023-09-12 | Traditional | PDF ↗ |
| K223550 | DMX | Del Medical, Inc. | 2023-04-10 | Abbreviated | PDF ↗ |
| K230241 | Jumong General | Sg Healthcare Co, Ltd. | 2023-02-23 | Special | PDF ↗ |
| K223842 | DRX - Compass | Carestream Health, Inc. | 2023-01-20 | Special | PDF ↗ |
| K223060 | DigiX FDX | Allengers Medical Systems Limited | 2022-10-26 | Special | PDF ↗ |
| K221853 | OTC DDR | Konica Minolta Healthcare Americas, Inc. | 2022-07-27 | Special | PDF ↗ |
| K220919 | MULTIX Impact E | Siemens Medical Solutions USA, Inc. | 2022-05-17 | Traditional | PDF ↗ |
| K220271 | Hand Diagnostic Radiography Imaging System | Nanoray Biotech Co., Ltd. | 2022-04-29 | Traditional | PDF ↗ |
| K220149 | General Radiography X-ray System (Model: GR10X 40K), General Radiography X-ray System (Model: GR10X 50K) | Xera Medical Systems & Technology , Ltd. | 2022-04-19 | Traditional | PDF ↗ |
| K220518 | SKANRAD 400 | Skanray Technologies Limited | 2022-04-01 | Traditional | PDF ↗ |
| K213057 | ExamVue Duo | Jpi Healthcare Co, Ltd. | 2022-02-18 | Traditional | PDF ↗ |
| K214012 | Straight Arm DDR | Konica Minolta Healthcare Americas, Inc. | 2022-01-12 | Special | PDF ↗ |
| K212186 | Philips Radiology Smart Assistant | Philips Medical Systems Dmc GmbH | 2021-12-13 | Traditional | PDF ↗ |
| K213700 | MULTIX Impact, MULTIX Impact C | Siemens Medical Solutions USA, Inc. | 2021-12-13 | Special | PDF ↗ |
| K210692 | DigitalDiagnost | Philips Medical Systems Dmc GmbH | 2021-04-02 | Special | PDF ↗ |
| K203537 | Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic Systems | Sedecal., Sa. | 2021-02-01 | Abbreviated | PDF ↗ |
| K203345 | MULTIX Impact | Siemens Medical Solutions USA, Inc. | 2021-01-07 | Traditional | PDF ↗ |
| K203340 | MULTIX Impact C | Siemens Medical Solutions USA, Inc. | 2021-01-06 | Traditional | PDF ↗ |
| K202388 | Apolo D / Apolo S | Vmi Tecnologias Ltda | 2020-12-01 | Abbreviated | PDF ↗ |
| K201825 | MiniCAT 2D | Xoran Technologies, LLC | 2020-11-20 | Traditional | PDF ↗ |
| K201670 | YSIO X.pree | Siemens Medical Solutions USA, Inc. | 2020-10-21 | Traditional | PDF ↗ |
| K202293 | Radiographic System Challenge X | Sedecal., Sa. | 2020-10-07 | Abbreviated | PDF ↗ |
| K202572 | GXR-Series Diagnostic X-Ray System | DRGEM Corporation | 2020-09-24 | Special | PDF ↗ |
| K202394 | EOSedge | Eos Imaging | 2020-09-16 | Special | PDF ↗ |
| K202156 | DIAMOND-5A/6A/8A | DRGEM Corporation | 2020-09-10 | Special | PDF ↗ |
| K201725 | DigitalDiagnost C50 | Philips Healthcare (Suzhou) Co., Lit. | 2020-07-10 | Special | PDF ↗ |
| K201640 | DuraDiagnost | Philips Healthcare (Suzhou) Co., Ltd. | 2020-07-09 | Special | PDF ↗ |
| K201373 | DRX-Compass | Carestream Health, Inc. | 2020-06-26 | Special | PDF ↗ |
| K200944 | UNIEXPERT 2 PLUS | Adani | 2020-05-26 | Traditional | PDF ↗ |
| K193089 | MULTIX Impact | Siemens Medical Solutions USA, Inc. | 2020-03-20 | Traditional | PDF ↗ |
| K193637 | MRH ALFA Radiographic System, MRH II Radiographic System, MRH IIE Radiographic System | Compania Mexicana DE Radiologia Cgr, S.A. DE C.V. | 2020-01-28 | Special | PDF ↗ |
| K193574 | Q-Rad System | Carestream Health, Inc. | 2020-01-22 | Special | PDF ↗ |
| K193225 | KDR AU-DDR System Advanced U-Arm with Dynamic Digital Radiography, KDR AU System Advanced U-Arm with Static Digital Radiography | Konica Minolta Healthcare Americas, Inc. | 2020-01-15 | Traditional | PDF ↗ |
| K193360 | Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard | Radmedix, LLC | 2020-01-02 | Traditional | PDF ↗ |
| K191879 | DRX-Evolution with Carestream Digital Tomosynthesis | Carestream Health, Inc. | 2019-12-20 | Traditional | PDF ↗ |
| K192079 | EOSedge | Eos Imaging | 2019-11-27 | Traditional | PDF ↗ |
| K190330 | DRX-Evolution/Plus with Dual Energy | Carestream Health, Inc. | 2019-11-04 | Traditional | PDF ↗ |
| K192541 | DigiX FDX | Allengers Medical Systems Limited | 2019-10-16 | Special | PDF ↗ |
| K192453 | DIAMOND-5A/6A/8A | DRGEM Corporation | 2019-10-01 | Special | PDF ↗ |
| K192364 | GXR-Series Diagnostic X-Ray System | DRGEM Corporation | 2019-09-26 | Traditional | PDF ↗ |
| K192293 | uDR 592h, uDR 596i | Shanghai United Imaging Healthcare Co., Ltd. | 2019-09-12 | Special | PDF ↗ |
| K191699 | Discovery XR656 HD with VolumeRad | Ge Hualun Medical Systems Co. , Ltd. | 2019-07-24 | Traditional | PDF ↗ |
| K191418 | Multix Fusion Max | Siemens Medical Solutions USA, Inc. | 2019-06-19 | Special | PDF ↗ |
| K190601 | MasteRad MX30 | Medicatech USA | 2019-04-25 | Traditional | PDF ↗ |
| K183541 | ProRad 2FC and ProRad 3NC Stationary Radiographic Systems | Prognosys Medical Systems Private Limited | 2019-01-24 | Traditional | PDF ↗ |
| K182517 | MULTIX Impact | Siemens Medi Cal Solutions, Inc. | 2019-01-11 | Traditional | PDF ↗ |
| K182183 | GC70, GU60A, GU60A-65, GF50, GR50A ; GR40CW ; GM85 ; GC85A | Samsung Electronics Co., Ltd. | 2018-12-07 | Traditional | PDF ↗ |
| K182134 | ARiX RAD Radiographic System | Compania Mexicana DE Radiologia Cgr, S.A. DE C.V. | 2018-11-26 | Traditional | PDF ↗ |
| K182880 | Halifax Imaging Kit | Halifax Biomedical, Inc. | 2018-10-31 | Special | PDF ↗ |
| K182647 | GC70 | Samsung Electronics Co., Ltd. | 2018-10-24 | Special | PDF ↗ |
| K182622 | GU60A, GU60A-65 | Samsung Electronics Co., Ltd. | 2018-10-23 | Special | PDF ↗ |
| K181629 | GC85A | Samsung Electronics Co., Ltd. | 2018-07-20 | Traditional | PDF ↗ |
| K181413 | uDR 592h, uDR 596i | Shanghai United Imaging Healthcare Co., Ltd. | 2018-06-27 | Traditional | PDF ↗ |
| K181279 | Ysio Max | Siemens Medi Cal Solutions, Inc. | 2018-06-13 | Special | PDF ↗ |
| K180543 | GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85 | Samsung Electronics Co., Ltd. | 2018-05-24 | Traditional | PDF ↗ |
| K180663 | LaVid FMTS DIAGNOSTIC X-RAY SYSTEM | Livermoretech, Inc. | 2018-05-18 | Traditional | PDF ↗ |
| K180765 | Televere Podiatry X-Ray System HF | Televere Systems, Inc. | 2018-04-20 | Traditional | PDF ↗ |
| K173517 | RADspeed fit | Shimadzu Corporation | 2018-03-30 | Traditional | PDF ↗ |
| K173823 | Amrad Medical AAU Digital Radiography System; Amrad Medical AAU Plus Digital Radiography System; Amrad Medical DFMT Digital Radiography System; Amrad Medical FMT Digital Radiography System | Summit Industries, LLC | 2018-02-09 | Traditional | PDF ↗ |
| K173953 | uDR 780i | Shanghai United Imaging Healthcare Co., Ltd. | 2018-01-26 | Traditional | PDF ↗ |
| K173828 | GU60A & GU60A-65 | Samsung Electronics Co., Ltd. | 2018-01-12 | Traditional | PDF ↗ |
| K173612 | Optima XR646 HD | Ge Hualun Medical Systems Co. , Ltd. | 2017-12-11 | Special | PDF ↗ |
| K172229 | GC85A | Samsung Electronics Co., Ltd. | 2017-11-22 | Traditional | PDF ↗ |
| K172869 | Discovery XR656 HD | Ge Hualun Medical Systems Co. , Ltd. | 2017-10-20 | Special | PDF ↗ |
| K162529 | DigiX FDX | Allengers Medical Systems Limited | 2017-03-03 | Traditional | PDF ↗ |
| K160857 | HF 718BD X-Ray System | Arquilla, Inc. Dba X-Cel X-Ray Corporation | 2017-02-24 | Traditional | PDF ↗ |
| K163410 | DigitalDiagnost C50 | Philips Healthcare (Suzhou) Co., Ltd. | 2017-01-04 | Special | PDF ↗ |
| K163203 | Carestream DRX-Evolution | Carestream Health, Inc. | 2016-12-13 | Special | PDF ↗ |
| K163115 | GC70 | Samsung Electronics Co., Ltd. | 2016-12-07 | Traditional | PDF ↗ |
| K152813 | FS-500DDR Medical Radiographic X-Ray System | Orich Medical Equipment (Tianjin) Co., Ltd. | 2016-12-02 | Traditional | PDF ↗ |
Product code KPR · Class II · Radiology. Data: openFDA.