HOLOGIC QDR-1000/W X-RAY BONE DENSITOMETER

Densitometer, Bone

HOLOGIC, INC.

The following data is part of a premarket notification filed by Hologic, Inc. with the FDA for Hologic Qdr-1000/w X-ray Bone Densitometer.

Pre-market Notification Details

Device IDK894795
510k NumberK894795
Device Name:HOLOGIC QDR-1000/W X-RAY BONE DENSITOMETER
ClassificationDensitometer, Bone
Applicant HOLOGIC, INC. 590 LINCOLN ST. Waltham,  MA  02154
ContactHoward P Weiss
CorrespondentHoward P Weiss
HOLOGIC, INC. 590 LINCOLN ST. Waltham,  MA  02154
Product CodeKGI  
CFR Regulation Number892.1170 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-07-20
Decision Date1990-08-30

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