510(k) K152162
K152162 is an FDA 510(k) premarket notification submitted by Cefla S.C. for the device "Myray- HYPERION X5". The FDA issued a decision of Substantially Equivalent on December 24, 2015. The device falls under product code MUH (System, X-Ray, Extraoral Source, Digital), a Class II device regulated under 21 CFR 872.1800. Cefla S.C. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 24, 2015
- Date Received
- August 3, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Extraoral Source, Digital
- Device Class
- Class II
- Regulation Number
- 872.1800
- Review Panel
- RA
- Submission Type