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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Nuclear Magnetic Resonance Imaging
510(k) Number K052023
Device Name CADIMAS VERSION 1.0
Applicant
ALAN PENN & ASSOCIATES., INC.
6319 MASSACHUSETTS AVENUE
BETHESDA,  MD  20816 -1139
Applicant Contact ROGER H SCHNEIDER
Correspondent
ALAN PENN & ASSOCIATES., INC.
6319 MASSACHUSETTS AVENUE
BETHESDA,  MD  20816 -1139
Correspondent Contact ROGER H SCHNEIDER
Regulation Number892.1000
Classification Product Code
LNH  
Subsequent Product Code
LLZ  
Date Received07/26/2005
Decision Date 12/08/2005
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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