Product code KPR
- Device name
- System, X-Ray, Stationary
- Medical specialty
- Radiology
- Device class
- 2
- Regulation number
- 892.1680
- Review panel
- RA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253446 | AeroDR TX c02 | Dk Medical Systems Co., Ltd. | 2026-04-10 |
| 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 |
| K252000 | uDR Arria & uDR Aris | Shanghai United Imaging Healthcare Co., Ltd. | 2025-11-26 |
| K251167 | uDR Aurora CX | Shanghai United Imaging Healthcare Co., Ltd. | 2025-09-19 |
| K250788 | Definium Tempo Select | Ge Hualun Medical Systems Co. , Ltd. | 2025-08-28 |
| K250790 | INNOVISION-DXII | Dk Medical Systems Co., Ltd. | 2025-08-01 |
| K250738 | YSIO X.pree | Siemens Medical Solutions | 2025-07-31 |
| K242019 | GXR-Series Diagnostic X-Ray System | DRGEM Corporation | 2025-01-07 |
| K242499 | Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E)) | Shenzhen Sontu Medical Imaging Equipment Co., Ltd. | 2025-01-06 |
| K242119 | INNOVISION-EXII | Dk Medical System | 2025-01-03 |
| K241068 | uDR 780i | Shanghai United Imaging Healthcare Co., Ltd. | 2024-11-01 |
| 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-D402... | DRTECH Corporation | 2024-10-23 |
| K242678 | Definium Pace Select ET | Ge Hualun Medical Systems Co. , Ltd. | 2024-10-01 |
| K242478 | GF85 (models GF85-3P, GF85-SP) | Samsung Electronics Co., Ltd. | 2024-09-19 |
| K233920 | EOSedge | Eos Imaging | 2024-08-06 |
| 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-D402... | DRTECH Corporation | 2024-07-26 |
| K233662 | Radiography 7300 C | Philips Medical Systems Dmc GmbH | 2024-06-13 |
| K233543 | YSIO X.pree | Siemens Medical Solutions | 2024-05-21 |
| K233719 | FDR Visionary Suite | Shimadzu Corporation | 2024-03-28 |
| K233381 | DRX-Evolution Plus System | Carestream Health, Inc. | 2024-03-12 |
| K233722 | RADspeed Pro | Shimadzu Corporation | 2024-02-23 |
| K233532 | MULTIX Impact E | Siemens Medical Solutions | 2023-11-29 |
| K230800 | XVISION-525, HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F PF50 | GEMSS HEALTHCARE CO., LTD. | 2023-11-02 |
| K231761 | PodSKAN HF Diagnostic X-ray System | Skanray Technologies Limited | 2023-10-27 |
| K231995 | AcuityUDR | Radmedix, LLC | 2023-10-25 |
| K232178 | GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series) | DRGEM Corporation | 2023-09-19 |
| K231892 | Definium Pace Select | Ge Hualun Medical Systems Co. , Ltd. | 2023-09-12 |
| K223550 | DMX | Del Medical, Inc. | 2023-04-10 |
| K230241 | Jumong General | Sg Healthcare Co, Ltd. | 2023-02-23 |
| K223842 | DRX - Compass | Carestream Health, Inc. | 2023-01-20 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08436046003033 | SEDECAL | SEDECAL | 2021-02-15 |
| 08436046003026 | SEDECAL | SEDECAL | 2021-02-15 |
| 08800011121297 | FDR Clinica | DRGEM Corporation | 2019-11-20 |
| 08800011121280 | FDR Clinica | DRGEM Corporation | 2019-11-20 |
| 08800011121273 | FDR Clinica | DRGEM Corporation | 2019-11-20 |
| 08800011121266 | FDR Clinica | DRGEM Corporation | 2019-11-20 |
| 08800011121259 | FDR Clinica | DRGEM Corporation | 2019-11-20 |
| 08800011121242 | FDR Clinica | DRGEM Corporation | 2019-11-20 |
| 08800011121235 | FDR Clinica | DRGEM Corporation | 2019-11-20 |
| 08436046002333 | SEDECAL | SEDECAL | 2018-05-01 |
| 08436046002340 | SEDECAL | SEDECAL | 2018-05-01 |
| 08436046002296 | SEDECAL | SEDECAL | 2017-02-15 |
| 08436046002302 | SEDECAL | SEDECAL | 2017-02-15 |
| 08436046002319 | SEDECAL | SEDECAL | 2017-02-15 |
| 08436046002234 | SEDECAL | SEDECAL | 2016-10-31 |
| 08436046002142 | SEDECAL | SEDECAL | 2016-10-31 |
| 08436046002135 | SEDECAL | SEDECAL | 2016-10-31 |
| 08436046002128 | SEDECAL | SEDECAL | 2016-10-31 |
| 08436046001176 | SEDECAL | SEDECAL | 2016-10-31 |
| 08436046001909 | SEDECAL | SEDECAL | 2016-10-31 |
| 08436046001916 | SEDECAL | SEDECAL | 2016-10-31 |
| 08436046002050 | SEDECAL | SEDECAL | 2016-10-31 |
| 08436046001923 | SEDECAL | SEDECAL | 2016-10-31 |
| 08436046000940 | SEDECAL | SEDECAL | 2016-10-28 |
| 08436046000964 | SEDECAL | SEDECAL | 2016-10-28 |
| 08436046000933 | SEDECAL | SEDECAL | 2016-10-28 |
| 08606102809132 | VISION | VISARIS DOO | 2016-10-13 |
| 08606102809125 | VISION | VISARIS DOO | 2016-10-13 |
| 08606102809118 | VISION | VISARIS DOO | 2016-10-13 |
| 08606102809101 | VISION | VISARIS DOO | 2016-10-11 |