K162039 is an FDA 510(k) clearance for the OptosAdvance 4.0 Software. This device is classified as a System, Image Management, Ophthalmic (Class II - Special Controls, product code NFJ).
Submitted by Optos Plc. (Dunfermline, GB). The FDA issued a Cleared decision on February 8, 2017, 201 days after receiving the submission on July 22, 2016.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 892.2050.
| 510(k) Number | K162039 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 22, 2016 |
| Decision Date | February 08, 2017 |
| Days to Decision | 201 days |
| Submission Type | Traditional |
| 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 |