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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Solid State X-Ray Imager (Flat Panel/Digital Imager)
510(k) Number K012750
Device Name ADC PEDIATRIC
Applicant
AGFA CORP.
12300 TWINBROOK PKWY,STE 625
ROCKVILLE,  MD  20852
Applicant Contact T. WHIT ATHEY
Correspondent
AGFA CORP.
12300 TWINBROOK PKWY,STE 625
ROCKVILLE,  MD  20852
Correspondent Contact T. WHIT ATHEY
Regulation Number892.1680
Classification Product Code
MQB  
Date Received08/16/2001
Decision Date 11/14/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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