510(k) K122428
K122428 is an FDA 510(k) premarket notification submitted by Faxitron Bioptics, LLC for the device "FAXITRON SPECIEN RADIOGRAPHY SYSTEM". The FDA issued a decision of Substantially Equivalent on September 25, 2012. The device falls under product code MWP (Cabinet, X-Ray System), a Class II device regulated under 21 CFR 892.1680. Faxitron Bioptics, LLC has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 25, 2012
- Date Received
- August 9, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cabinet, X-Ray System
- Device Class
- Class II
- Regulation Number
- 892.1680
- Review Panel
- RA
- Submission Type