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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accelerator, Linear, Medical
510(k) Number K920455
Device Name THERAVIEW DIGITAL PORTAL IMAGING COMPUTER (MOD.)
Applicant
S & S Inficon, Inc.
121 Metropolitan Dr.
Liverpool,  NY  13088
Applicant Contact TIMOTHY A DERRIGAN
Correspondent
S & S Inficon, Inc.
121 Metropolitan Dr.
Liverpool,  NY  13088
Correspondent Contact TIMOTHY A DERRIGAN
Regulation Number892.5050
Classification Product Code
IYE  
Date Received01/16/1992
Decision Date 03/31/1992
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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