The following data is part of a premarket notification filed by Carestream Health, Inc. with the FDA for Cs 7600.
| Device ID | K111649 |
| 510k Number | K111649 |
| Device Name: | CS 7600 |
| Classification | System, X-ray, Extraoral Source, Digital |
| 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 | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-13 |
| Decision Date | 2011-09-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 60192151068403 | K111649 | 000 |
| 60192151067475 | K111649 | 000 |
| 60192151044445 | K111649 | 000 |
| 60192151023716 | K111649 | 000 |
| 60192151023709 | K111649 | 000 |
| 60192151014318 | K111649 | 000 |
| 60192151014301 | K111649 | 000 |
| 60192151018903 | K111649 | 000 |