510(k) K981556

CANON X-RAY DIGITAL CAMERA CXDI-11 by Canon USA, Inc. — Product Code MQB

K981556 is an FDA 510(k) premarket notification submitted by Canon USA, Inc. for the device "CANON X-RAY DIGITAL CAMERA CXDI-11". The FDA issued a decision of Substantially Equivalent on November 4, 1998. 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 4, 1998
Date Received
May 1, 1998
Clearance Type
Traditional
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