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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Digital Image Storage, Radiological
510(k) Number K884990
Device Name IMS-3 PICTURE ARCHIVING SYSTEM
Applicant
THE BIOMEDICAL ENGINEERING CENTER
9342 TECH CENTER DR.
SUITE 100
SACRAMENTO,  CA  95826
Applicant Contact R MCCUSKER
Correspondent
THE BIOMEDICAL ENGINEERING CENTER
9342 TECH CENTER DR.
SUITE 100
SACRAMENTO,  CA  95826
Correspondent Contact R MCCUSKER
Regulation Number892.2010
Classification Product Code
LMB  
Date Received12/01/1988
Decision Date 03/23/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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