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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 K895320
Device Name FLUOROVISION HR 2000 HIGH RESOLUTION IMAGE ENHANCE
Applicant
Digivision, Inc.
45 W. St.
Suite 2
North Attleboro,  MA  02703
Applicant Contact JAMES VEALE
Correspondent
Digivision, Inc.
45 W. St.
Suite 2
North Attleboro,  MA  02703
Correspondent Contact JAMES VEALE
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received08/29/1989
Decision Date 11/01/1989
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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