ASTRA


Device Classification Name

system, image processing, radiological

510(k) Number K111694
Device Name ASTRA
Applicant
CANDELIS, INC.
18821 bardeen ave.
irvine, 
CA 
92612

Applicant Contact vincent cipolla
Correspondent
CANDELIS, INC.
18821 bardeen ave.
irvine, 
CA 
92612

Correspodent Contact vincent cipolla
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 06/16/2011
Decision Date 09/15/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No