510(k) K173478
K173478 is an FDA 510(k) premarket notification submitted by Carestream Health, Inc. for the device "OnSight 3D Extremity System". The FDA issued a decision of Substantially Equivalent on Jan 19, 2018. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. Carestream Health, Inc. has 52 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 19, 2018
- Date Received
- Nov 13, 2017
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Tomography, Computed
- Device Class
- Class II
- Regulation Number
- 892.1750
- Review Panel
- RA
- Submission Type
- 510(k)