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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 K142779
Device Name SCANIP; SCANIP: MEDICAL EDITION; SCANIP: MED
Applicant
SIMPLEWARE LTD.
BRADNINCH HALL, CASTLE STREET
EXETER,  GB EX43PL
Applicant Contact GARETH JAMES
Correspondent
SIMPLEWARE LTD.
BRADNINCH HALL, CASTLE STREET
EXETER,  GB EX43PL
Correspondent Contact GARETH JAMES
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received09/26/2014
Decision Date 04/17/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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