510(k) K050925
K050925 is an FDA 510(k) premarket notification submitted by Shimadzu Corp. for the device "DIGITAL RADIOGRAPHY SYSTEM RADSPEED SAFIRE". The FDA issued a decision of Substantially Equivalent on June 1, 2005. The device falls under product code MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager)), a Class II device regulated under 21 CFR 892.1680. Shimadzu Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 1, 2005
- Date Received
- April 13, 2005
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Solid State X-Ray Imager (Flat Panel/Digital Imager)
- Device Class
- Class II
- Regulation Number
- 892.1680
- Review Panel
- RA
- Submission Type