The following data is part of a premarket notification filed by Carestream Health, Inc. with the FDA for Carestream Pacs.
| Device ID | K110919 |
| 510k Number | K110919 |
| Device Name: | CARESTREAM PACS |
| Classification | System, Image Processing, Radiological |
| Applicant | CARESTREAM HEALTH, INC. 150 VERONA STREET Rochester, NY 14608 |
| Contact | Linda Stewart |
| Correspondent | Linda Stewart CARESTREAM HEALTH, INC. 150 VERONA STREET Rochester, NY 14608 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-01 |
| Decision Date | 2011-10-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 60889971047809 | K110919 | 000 |
| 60889971041692 | K110919 | 000 |
| 00884838100336 | K110919 | 000 |