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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 K902339
Device Name THERAVIEW DIGITAL PORTAL IMAGING COMPUTER
Applicant
S & S Inficon, Inc.
121 Metropolitan Dr.
Liverpool,  NY  13088
Applicant Contact C GREENWAY
Correspondent
S & S Inficon, Inc.
121 Metropolitan Dr.
Liverpool,  NY  13088
Correspondent Contact C GREENWAY
Regulation Number892.5050
Classification Product Code
IYE  
Date Received05/24/1990
Decision Date 08/23/1990
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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