1.10-YEAR FRACTURE RISK QUESTIONNAIRE OPTION FOR QDR X-RAY BONE DENSITOMETER, MODEL QDR OPTION


Device Classification Name

densitometer, bone

510(k) Number K080711
Device Name 1.10-YEAR FRACTURE RISK QUESTIONNAIRE OPTION FOR QDR X-RAY BONE DENSITOMETER, MODEL QDR OPTION
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 03/13/2008
Decision Date 09/02/2008
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