The following data is part of a premarket notification filed by Caliber Imaging & Diagnostics, Inc. with the FDA for Vivascope System.
| Device ID | K180162 |
| 510k Number | K180162 |
| Device Name: | VivaScope System |
| Classification | Light Based Imaging |
| Applicant | Caliber Imaging & Diagnostics, Inc. 50 Methodist Hill Dr. Suite 1000 Rochester, NY 14623 |
| Contact | Joel Radford |
| Correspondent | Joel Radford Caliber Imaging & Diagnostics, Inc. 50 Methodist Hill Dr. Suite 1000 Rochester, NY 14623 |
| Product Code | PSN |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-19 |
| Decision Date | 2018-05-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08602920003066 | K180162 | 000 |