K190357 is an FDA 510(k) clearance for the Star-X, Intraoral X-ray System. This device is classified as a Unit, X-ray, Extraoral With Timer (Class II - Special Controls, product code EHD).
Submitted by Hdx Will Corp. (Cheongju-Si, KR). The FDA issued a Cleared decision on March 15, 2019, 28 days after receiving the submission on February 15, 2019.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 872.1800.
| 510(k) Number | K190357 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 15, 2019 |
| Decision Date | March 15, 2019 |
| Days to Decision | 28 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | EHD - Unit, X-ray, Extraoral With Timer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.1800 |