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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 K960510
Device Name THERAVIEW
Applicant
Infimed, Inc.
121 Metropolitan Dr.
Liverpool,  NY  13088
Applicant Contact MORTEZA MINAEE
Correspondent
Infimed, Inc.
121 Metropolitan Dr.
Liverpool,  NY  13088
Correspondent Contact MORTEZA MINAEE
Regulation Number892.5050
Classification Product Code
IYE  
Date Received02/05/1996
Decision Date 04/22/1996
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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