The following data is part of a premarket notification filed by Carestream Health,inc. with the FDA for Carestream Vue Pacs Version 11.4 Carestream Vue Motion Application.
| Device ID | K132824 |
| 510k Number | K132824 |
| Device Name: | CARESTREAM VUE PACS VERSION 11.4 CARESTREAM VUE MOTION APPLICATION |
| Classification | System, Image Processing, Radiological |
| Applicant | CARESTREAM HEALTH,INC. 8708 CAPEHART COVE Austin, TX 78733 |
| Contact | David C Furr |
| Correspondent | David C Furr CARESTREAM HEALTH,INC. 8708 CAPEHART COVE Austin, TX 78733 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-09 |
| Decision Date | 2014-02-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 60889971048875 | K132824 | 000 |