The following data is part of a premarket notification filed by Michelson Diagnostics Ltd with the FDA for Vivosight Dx Topical Oct System.
| Device ID | K153283 |
| 510k Number | K153283 |
| Device Name: | VivoSight Dx Topical OCT System |
| Classification | System, Imaging, Optical Coherence Tomography (oct) |
| Applicant | Michelson Diagnostics Ltd Ground Floor Eclipse House, Eclipse Park, Sittingbourne Road Maidstone, GB Me14 3en |
| Contact | Martin Johns |
| Correspondent | Martin Johns Michelson Diagnostics Ltd Ground Floor Eclipse House, Eclipse Park, Sittingbourne Road Maidstone, GB Me14 3en |
| Product Code | NQQ |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-12 |
| Decision Date | 2016-08-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060507260012 | K153283 | 000 |