The following data is part of a premarket notification filed by Carestream Health,inc. with the FDA for Cs 1600 Intraoral Camera.
| Device ID | K111423 |
| 510k Number | K111423 |
| Device Name: | CS 1600 INTRAORAL CAMERA |
| Classification | Laser, Fluorescence Caries Detection |
| Applicant | CARESTREAM HEALTH,INC. 1765 THE EXCHANGE Atlanta, GA 30339 |
| Contact | Daniel Hoefer |
| Correspondent | Daniel Hoefer CARESTREAM HEALTH,INC. 1765 THE EXCHANGE Atlanta, GA 30339 |
| Product Code | NBL |
| CFR Regulation Number | 872.1745 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-23 |
| Decision Date | 2012-03-02 |
| Summary: | summary |