510(k) K023346
K023346 is an FDA 510(k) premarket notification submitted by Trophy Radiologie for the device "TROPHYPAN". The FDA issued a decision of Substantially Equivalent on January 3, 2003. 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
- January 3, 2003
- Date Received
- October 7, 2002
- 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