AXIS PACS, HMS PACS


Device Classification Name

system, image processing, radiological

510(k) Number K103679
Device Name AXIS PACS, HMS PACS
Applicant
AXIS HEALTH CARE, LLC
5755 carmichael parkway
montgomery, 
AL 
36117

Applicant Contact ronald w graham
Correspondent
AXIS HEALTH CARE, LLC
5755 carmichael parkway
montgomery, 
AL 
36117

Correspodent Contact ronald w graham
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 12/17/2010
Decision Date 03/03/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No