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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Digital Image Communications, Radiological
510(k) Number K921527
Device Name STATVIEW
Applicant
IMAGE DATA CORP.
P.O. BOX 690390
SAN ANTONIO,  TX  78269
Applicant Contact LARRY BUERK
Correspondent
IMAGE DATA CORP.
P.O. BOX 690390
SAN ANTONIO,  TX  78269
Correspondent Contact LARRY BUERK
Regulation Number892.2020
Classification Product Code
LMD  
Date Received04/03/1992
Decision Date 06/24/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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