The following data is part of a premarket notification filed by Carestream Health, Inc. with the FDA for Onsight 3d Extremity System.
| Device ID | K160723 |
| 510k Number | K160723 |
| Device Name: | OnSight 3D Extremity System |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | CARESTREAM HEALTH, INC. 150 VERONA STREET Rochester, NY 14608 |
| Contact | Carolyn Wagner |
| Correspondent | Carolyn Wagner CARESTREAM HEALTH, INC. 150 VERONA STREET Rochester, NY 14608 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-16 |
| Decision Date | 2016-08-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 60889971743572 | K160723 | 000 |
| 60889971743565 | K160723 | 000 |