K192453 is an FDA 510(k) clearance for the DIAMOND-5A/6A/8A. This device is classified as a System, X-ray, Stationary (Class II - Special Controls, product code KPR).
Submitted by DRGEM Corporation (Gwangmyeong-Si, KR). The FDA issued a Cleared decision on October 1, 2019, 22 days after receiving the submission on September 9, 2019.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1680.
| 510(k) Number | K192453 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 09, 2019 |
| Decision Date | October 01, 2019 |
| Days to Decision | 22 days |
| Submission Type | Special |
| 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 |