K230800 is an FDA 510(k) clearance for the XVISION-525, HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F PF50. This device is classified as a System, X-ray, Stationary (Class II - Special Controls, product code KPR).
Submitted by GEMSS HEALTHCARE CO., LTD. (Paju-Si, KR). The FDA issued a Cleared decision on November 2, 2023, 224 days after receiving the submission on March 23, 2023.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1680.
| 510(k) Number | K230800 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 23, 2023 |
| Decision Date | November 02, 2023 |
| Days to Decision | 224 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | KPR - System, X-ray, Stationary |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1680 |