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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Digital Image Communications, Radiological
510(k) Number K942917
Device Name ULTRAPRO WORKSTATION
Applicant
Ramsoft, Inc.
37 Bankview Cir.
Rexdale, Ontario,  CA M9W 6S6
Applicant Contact N RAMANATHAN
Correspondent
Ramsoft, Inc.
37 Bankview Cir.
Rexdale, Ontario,  CA M9W 6S6
Correspondent Contact N RAMANATHAN
Regulation Number892.2020
Classification Product Code
LMD  
Date Received06/21/1994
Decision Date 11/14/1994
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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