K191615 is an FDA 510(k) clearance for the Huvitz Imaging System. This device is classified as a System, Image Management, Ophthalmic (Class II - Special Controls, product code NFJ).
Submitted by Huvitz Co., Ltd. (Anyang-Si, Dongan-Gu, KR). The FDA issued a Cleared decision on July 18, 2019, 30 days after receiving the submission on June 18, 2019.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 892.2050.
| 510(k) Number | K191615 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 18, 2019 |
| Decision Date | July 18, 2019 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | NFJ - System, Image Management, Ophthalmic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.2050 |