IMAGECHECKER CT CAD SOFTWARE SYSTEM


Device Classification Name

lung computed tomography system, computer-aided detection

510(k) Number K043617
Device Name IMAGECHECKER CT CAD SOFTWARE SYSTEM
Applicant
HOLOGIC, INC.
35 crosby dr.
bedford, 
MA 
01730

Applicant Contact arthur friedman
Correspondent
HOLOGIC, INC.
35 crosby dr.
bedford, 
MA 
01730

Correspodent Contact arthur friedman
Regulation Number 892.2050
Classification Product Code
OEB  
Date Received 11/26/2007
Decision Date 12/21/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

Type Traditional
Reviewed by Third Party No

Combination Product

No