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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 K043146
Device Name HORIZON MEDICAL IMAGING
Applicant
MCKESSON MEDICAL IMAGING COMPANY
130-10711 CAMBIE ROAD
richmond, b.c.,  CA v6x 3g5
Applicant Contact robert macneil
Correspondent
ENTELA, INC.
3033 MADISON AVENUE, SE
grand rapids,  MI  49548
Correspondent Contact neil e devine
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received11/15/2004
Decision Date 01/04/2005
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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