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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 K952313
Device Name VARIS IMAGES, INCLUDING XIMATRON DIGITAL IMAGING OPTION
Applicant
Varian Assoc., Inc.
3045 Hanover St.
Mail Stop H-055
Palo Alto,  CA  94304
Applicant Contact LUANNE TERMEER
Correspondent
Varian Assoc., Inc.
3045 Hanover St.
Mail Stop H-055
Palo Alto,  CA  94304
Correspondent Contact LUANNE TERMEER
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received05/17/1995
Decision Date 08/16/1995
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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