510(k) K023586

DR-ER VERFSION OF CANON X-RAY DIGITAL CAMERAS by Canon USA, Inc. — Product Code MQB

K023586 is an FDA 510(k) premarket notification submitted by Canon USA, Inc. for the device "DR-ER VERFSION OF CANON X-RAY DIGITAL CAMERAS". The FDA issued a decision of Substantially Equivalent on November 5, 2002. 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 USA, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 2002
Date Received
October 25, 2002
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