510(k) K103591
K103591 is an FDA 510(k) premarket notification submitted by Canon Inc. -Medical Equipment Group for the device "DIGITAL RADIOGRAPHY". The FDA issued a decision of Substantially Equivalent on March 29, 2011. 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. Canon Inc. -Medical Equipment Group has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 29, 2011
- Date Received
- December 7, 2010
- Clearance Type
- Special
- 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