The following data is part of a premarket notification filed by Carestream Health, Inc. with the FDA for Carestream Vue Pacs.
| Device ID | K122523 |
| 510k Number | K122523 |
| Device Name: | CARESTREAM VUE PACS |
| Classification | System, Image Processing, Radiological |
| Applicant | CARESTREAM HEALTH, INC. 150 VERONA STREET Rochester, NY 14608 |
| Contact | Alexandra Chamberlain |
| Correspondent | Alexandra Chamberlain 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 | 2012-08-20 |
| Decision Date | 2012-10-23 |