The following data is part of a premarket notification filed by Carestream Health, Inc. with the FDA for Onsight 3d Extremity System.
| Device ID | K173478 |
| 510k Number | K173478 |
| Device Name: | OnSight 3D Extremity System |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 |
| Contact | Victoria A. Wheeler |
| Correspondent | Victoria A. Wheeler Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-13 |
| Decision Date | 2018-01-19 |