510(k) K043146

HORIZON MEDICAL IMAGING by Mckesson Medical Imaging Company — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 4, 2005
Date Received
November 15, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
System, Image Processing, Radiological
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type