KPR — System, X-Ray, Stationary Class II
FDA product code KPR covers "System, X-Ray, Stationary", a Class II medical device regulated under 21 CFR 892.1680. Submissions are reviewed by the Radiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K260482 | jpi healthcare co | DRE Duo | June 15, 2026 |
| K253446 | dk medical systems co | AeroDR TX c02 | April 10, 2026 |
| K250954 | carestream health | DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 dete | January 20, 2026 |
| K252000 | shanghai united imaging healthcare co | uDR Arria & uDR Aris | November 26, 2025 |
| K251167 | shanghai united imaging healthcare co | uDR Aurora CX | September 19, 2025 |
| K250788 | ge hualun medical systems co. | Definium Tempo Select | August 28, 2025 |
| K250790 | dk medical systems co | INNOVISION-DXII | August 1, 2025 |
| K250738 | siemens medical solutions | YSIO X.pree | July 31, 2025 |
| K242019 | drgem corporation | GXR-Series Diagnostic X-Ray System | January 7, 2025 |
| K242499 | shenzhen sontu medical imaging equipment co | Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E)) | January 6, 2025 |
| K242119 | dk medical system | INNOVISION-EXII | January 3, 2025 |
| K241068 | shanghai united imaging healthcare co | uDR 780i | November 1, 2024 |
| K242847 | drtech corporation | EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi | October 23, 2024 |
| K242678 | ge hualun medical systems co. | Definium Pace Select ET | October 1, 2024 |
| K242478 | samsung electronics co | GF85 (models GF85-3P, GF85-SP) | September 19, 2024 |
| K233920 | eos imaging | EOSedge | August 6, 2024 |
| K233530 | drtech corporation | EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi | July 26, 2024 |
| K233662 | philips medical systems dmc | Radiography 7300 C | June 13, 2024 |
| K233543 | siemens medical solutions | YSIO X.pree | May 21, 2024 |
| K233719 | shimadzu corporation | FDR Visionary Suite | March 28, 2024 |