INTEGRADWEB PACS SYSTEM


Device Classification Name

system, image processing, radiological

510(k) Number K072986
Device Name INTEGRADWEB PACS SYSTEM
Applicant
GE HEALTHCARE
25 walnut street
monroe, 
CT 
06468

Applicant Contact jillian m reed
Correspondent
GE HEALTHCARE
25 walnut street
monroe, 
CT 
06468

Correspodent Contact jillian m reed
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 10/23/2007
Decision Date 11/20/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

Type Special
Reviewed by Third Party No

Combination Product

No