The following data is part of a premarket notification filed by Carestream Health, Inc. with the FDA for Carestream Vue Pacs.
| Device ID | K170580 |
| 510k Number | K170580 |
| Device Name: | Carestream Vue PACS |
| Classification | System, Image Processing, Radiological |
| Applicant | Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 |
| 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 | 2017-02-28 |
| Decision Date | 2017-04-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838100350 | K170580 | 000 |
| 00884838103504 | K170580 | 000 |