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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, image processing, radiological
510(k) Number K970402
Device Name DOCTORS REVIEW SYSTEM
Applicant
DIGISONICS, INC.
3701 KIRBY DR., SUITE 930
HOUSTON,  TX  77098
Applicant Contact DIANA MC SHERRY, PH.D
Correspondent
DIGISONICS, INC.
3701 KIRBY DR., SUITE 930
HOUSTON,  TX  77098
Correspondent Contact DIANA MC SHERRY, PH.D
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received02/03/1997
Decision Date 03/26/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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