HOLOGIC QDR X-RAY BONE DENSITOMETER, MODELS 1000, 2000, 4500, DELPHI, DISCOVERY


Device Classification Name

densitometer, bone

510(k) Number K023398
Device Name HOLOGIC QDR X-RAY BONE DENSITOMETER, MODELS 1000, 2000, 4500, DELPHI, DISCOVERY
Original Applicant
HOLOGIC, INC.
35 crosby dr.
bedford, 
MA 
01730

Original Contact richard l follett
Regulation Number 892.1170
Classification Product Code
KGI  
Date Received 10/09/2002
Decision Date 11/08/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No