510(k) K090623

DIGITAL RADIOGRAPHY CXDI-40G COMPACT by Canon USA, Inc. — Product Code MQB

K090623 is an FDA 510(k) premarket notification submitted by Canon USA, Inc. for the device "DIGITAL RADIOGRAPHY CXDI-40G COMPACT". The FDA issued a decision of Substantially Equivalent on March 24, 2009. 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
March 24, 2009
Date Received
March 9, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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