K193319 is an FDA 510(k) clearance for the XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System. This device is classified as a Camera, Ophthalmic, Ac-powered (Class II - Special Controls, product code HKI).
Submitted by Vasoptic Medical, Inc. (Baltimore, US). The FDA issued a Cleared decision on June 1, 2020, 182 days after receiving the submission on December 2, 2019.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1120.
| 510(k) Number | K193319 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 02, 2019 |
| Decision Date | June 01, 2020 |
| Days to Decision | 182 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HKI - Camera, Ophthalmic, Ac-powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.1120 |