The following data is part of a premarket notification filed by Carestream Health, Inc. with the FDA for Carestream Vue Pacs.
| Device ID | K153103 |
| 510k Number | K153103 |
| Device Name: | CARESTREAM Vue PACS |
| Classification | System, Image Processing, Radiological |
| Applicant | CARESTREAM HEALTH, INC. 150 VERONA STREET Rochester, NY 14468 |
| Contact | Diane Koetter |
| Correspondent | Diane Koetter 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 | 2015-10-26 |
| Decision Date | 2016-02-12 |
| Summary: | summary |