510(k) K012514
K012514 is an FDA 510(k) premarket notification submitted by Trophy Radiologie for the device "DIGIPAN / DPI". The FDA issued a decision of Substantially Equivalent on December 21, 2001. The device falls under product code MUH (System, X-Ray, Extraoral Source, Digital), a Class II device regulated under 21 CFR 872.1800. Trophy Radiologie has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 21, 2001
- Date Received
- August 6, 2001
- 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