AXXENT RADIATION SHIELD – RIGID


Device Classification Name

system, therapeutic, x-ray

510(k) Number K111299
Device Name AXXENT RADIATION SHIELD – RIGID
Applicant
XOFT, AN ICAD COMPANY
345 potrero avenue
sunnyvale, 
CA 
94085

Applicant Contact steve lin
Correspondent
XOFT, AN ICAD COMPANY
345 potrero avenue
sunnyvale, 
CA 
94085

Correspodent Contact steve lin
Regulation Number 892.5900
Classification Product Code
JAD  
Date Received 05/09/2011
Decision Date 07/20/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No