510(k) K162314
K162314 is an FDA 510(k) premarket notification submitted by Imactis, Sas for the device "IMACTIS CT-Navigation system". The FDA issued a decision of Substantially Equivalent on April 24, 2018. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 24, 2018
- Date Received
- August 18, 2016
- Clearance Type
- Traditional
- 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