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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 K002789
Device Name MEDEVIEW SYSTEM
Applicant
Medeview.Com
1400 Main St.
Suite 120
Walthan,  MA  02451
Applicant Contact JEFFREY O BOILY
Correspondent
Medeview.Com
1400 Main St.
Suite 120
Walthan,  MA  02451
Correspondent Contact JEFFREY O BOILY
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received09/07/2000
Decision Date 03/21/2001
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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