FLAT PANEL DETECTOR


Device Classification Name

solid state x-ray imager (flat panel/digital imager)

510(k) Number K111824
Device Name FLAT PANEL DETECTOR
Applicant
CANON, INC.-MEDICAL EQUIPMENT GROUP
1201 richardson drive
suite 280
richardson, 
TX 
75080

Applicant Contact diane rutherford
Correspondent
CANON, INC.-MEDICAL EQUIPMENT GROUP
1201 richardson drive
suite 280
richardson, 
TX 
75080

Correspodent Contact diane rutherford
Regulation Number 892.1680
Classification Product Code
MQB  
Date Received 06/28/2011
Decision Date 04/23/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

Type Traditional
Reviewed by Third Party No

Combination Product

No