The following data is part of a premarket notification filed by Cariescan Ltd. with the FDA for Remote View Software.
| Device ID | K111321 |
| 510k Number | K111321 |
| Device Name: | REMOTE VIEW SOFTWARE |
| Classification | Laser, Fluorescence Caries Detection |
| Applicant | CARIESCAN LTD. UNIT 5 GATEWAY WEST, LUNA PLACE, TECHNOLOGY PARK Dundee, Angus, GB Dd2 1xz |
| Contact | Nikola Skelly |
| Correspondent | Nikola Skelly CARIESCAN LTD. UNIT 5 GATEWAY WEST, LUNA PLACE, TECHNOLOGY PARK Dundee, Angus, GB Dd2 1xz |
| Product Code | NBL |
| CFR Regulation Number | 872.1745 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-11 |
| Decision Date | 2011-05-17 |