The following data is part of a premarket notification filed by Carestream Health,inc. with the FDA for Dryview Chroma Imaging System.
| Device ID | K111566 |
| 510k Number | K111566 |
| Device Name: | DRYVIEW CHROMA IMAGING SYSTEM |
| Classification | Camera, Multi Format, Radiological |
| Applicant | CARESTREAM HEALTH,INC. 150 VERONA STREET Rochester, NY 14608 |
| Contact | Christine Ehamnn |
| Correspondent | Christine Ehamnn CARESTREAM HEALTH,INC. 150 VERONA STREET Rochester, NY 14608 |
| Product Code | LMC |
| CFR Regulation Number | 892.2040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-06 |
| Decision Date | 2011-10-06 |
| Summary: | summary |