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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 K926098
Device Name DIGIRAY
Applicant
TELESCAN CORP.
61 CASSATT AVE.
BERWYN,  PA  19312
Applicant Contact CHARLES MORRIS
Correspondent
TELESCAN CORP.
61 CASSATT AVE.
BERWYN,  PA  19312
Correspondent Contact CHARLES MORRIS
Regulation Number892.2020
Classification Product Code
LMD  
Date Received12/03/1992
Decision Date 06/25/1993
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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