APEX 2.0 SOFTWARE FOR QDR X-RAY BONE DENSITOMETERS


Device Classification Name

densitometer, bone

510(k) Number K072847
Device Name APEX 2.0 SOFTWARE FOR QDR X-RAY BONE DENSITOMETERS
Applicant
HOLOGIC, INC.
35 crosby dr.
bedford, 
MA 
01730

Applicant Contact bryan cowell
Correspondent
HOLOGIC, INC.
35 crosby dr.
bedford, 
MA 
01730

Correspodent Contact bryan cowell
Regulation Number 892.1170
Classification Product Code
KGI  
Date Received 10/04/2007
Decision Date 03/28/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls