The following data is part of a premarket notification filed by Optovue, Inc. with the FDA for Rtvue Xr Oct Avanti With Angiovue Software.
| Device ID | K153080 |
| 510k Number | K153080 |
| Device Name: | RTVue XR OCT Avanti With AngioVue Software |
| Classification | Ophthalmoscope, Ac-powered |
| Applicant | OPTOVUE, INC. 2800 BAYVIEW DRIVE Fremont, CA 94538 |
| Contact | Edward Sinclair |
| Correspondent | Edward Sinclair OPTOVUE, INC. 2800 BAYVIEW DRIVE Fremont, CA 94538 |
| Product Code | HLI |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-23 |
| Decision Date | 2016-02-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858848006469 | K153080 | 000 |
| 00858848006704 | K153080 | 000 |
| 00858848006667 | K153080 | 000 |
| 00858848006674 | K153080 | 000 |
| 00858848006001 | K153080 | 000 |
| 00858848006025 | K153080 | 000 |
| 00858848006032 | K153080 | 000 |
| 00858848006346 | K153080 | 000 |
| 00858848006353 | K153080 | 000 |
| 00858848006360 | K153080 | 000 |
| 00858848006377 | K153080 | 000 |
| 00858848006384 | K153080 | 000 |
| 00858848006391 | K153080 | 000 |
| 00858848006452 | K153080 | 000 |
| 00858848006728 | K153080 | 000 |