The following data is part of a premarket notification filed by Carestream Health, Inc. with the FDA for Carestream Pacs, Model Carestream Pacs Vii.
| Device ID | K083673 |
| 510k Number | K083673 |
| Device Name: | CARESTREAM PACS, MODEL CARESTREAM PACS VII |
| 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 | 2008-12-11 |
| Decision Date | 2008-12-30 |
| Summary: | summary |