The following data is part of a premarket notification filed by Carestream Health, Inc. with the FDA for Carestream Vue Motion.
| Device ID | K151774 |
| 510k Number | K151774 |
| Device Name: | CARESTREAM Vue Motion |
| Classification | System, Image Processing, Radiological |
| Applicant | CARESTREAM HEALTH, INC. 150 VERONA STREET Rochester, NY 14608 |
| Contact | Carolyn L Wagner |
| Correspondent | Carolyn L Wagner 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 | 2015-07-01 |
| Decision Date | 2015-09-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838100367 | K151774 | 000 |