The following data is part of a premarket notification filed by Optos Plc with the FDA for Optosadvance 4.0 Software.
| Device ID | K162039 |
| 510k Number | K162039 |
| Device Name: | OptosAdvance 4.0 Software |
| Classification | System, Image Management, Ophthalmic |
| Applicant | Optos Plc Queensferry House, Carnegie Campus, Enterprise Way Dunfermline, GB Ky11 8gr |
| Contact | Paul Burns |
| Correspondent | Randy Prebula Hogan Lovells U.S. LLP 555 Thirteenth Street NW Washington, DC 20004 |
| Product Code | NFJ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-22 |
| Decision Date | 2017-02-08 |
| Summary: | summary |