SECURVIEW DX DIAGNOSTIC WORKSTATION


Device Classification Name

system, image processing, radiological

510(k) Number K103385
Device Name SECURVIEW DX DIAGNOSTIC WORKSTATION
Applicant
HOLOGIC, INC.
36 apple ridge road
danbury, 
CT 
06810

Applicant Contact gail yaeker-daunis
Correspondent
HOLOGIC, INC.
36 apple ridge road
danbury, 
CT 
06810

Correspodent Contact gail yaeker-daunis
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 11/18/2010
Decision Date 02/02/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls