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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Multi Format, Radiological
510(k) Number K012010
Device Name MODIFICATION TO LR 5200 FILM RECORDER
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 Number892.2040
Classification Product Code
LMC  
Date Received06/27/2001
Decision Date 09/20/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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