The following data is part of a premarket notification filed by Abbott Medical with the FDA for Optis Mobile Next Imaging System, Optis Integrated Next Imaging System.
| Device ID | K210458 |
| 510k Number | K210458 |
| Device Name: | OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System |
| Classification | System, Imaging, Optical Coherence Tomography (oct) |
| Applicant | Abbott Medical 4 Robbins Road Westford, MA 01886 |
| Contact | Steve Vitale |
| Correspondent | Steve Vitale Abbott Medical 4 Robbins Road Westford, MA 01886 |
| Product Code | NQQ |
| Subsequent Product Code | DQK |
| Subsequent Product Code | DSK |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-16 |
| Decision Date | 2021-06-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05415067045331 | K210458 | 000 |
| 05415067033680 | K210458 | 000 |
| 05415067036629 | K210458 | 000 |
| 05415067036643 | K210458 | 000 |
| 05415067036681 | K210458 | 000 |
| 05415067036704 | K210458 | 000 |
| 05415067036728 | K210458 | 000 |
| 05415067036742 | K210458 | 000 |
| 05415067036810 | K210458 | 000 |
| 05415067036858 | K210458 | 000 |
| 05415067037145 | K210458 | 000 |
| 05415067037169 | K210458 | 000 |
| 05415067037183 | K210458 | 000 |
| 05415067037268 | K210458 | 000 |
| 05415067037558 | K210458 | 000 |
| 05415067047694 | K210458 | 000 |