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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 K993532
Device Name DDS, DS3000, RS3000, CS5000, OT3000, IS3000, RS5000, CD3000, US3000, (AMONGST OTHER NAMES)
Applicant
IMPAX TECHNOLOGY, INC.
455 PHILLIP ST.
WATERLOO, ONTARIO,  CA N2L 3X2
Applicant Contact PAULA PFEIFLE
Correspondent
IMPAX TECHNOLOGY, INC.
455 PHILLIP ST.
WATERLOO, ONTARIO,  CA N2L 3X2
Correspondent Contact PAULA PFEIFLE
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received10/19/1999
Decision Date 12/15/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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