DIGITAL SPOT MAMMOGRAPHY SYSTEM

System, X-ray, Mammographic

HOLOGIC, INC.

The following data is part of a premarket notification filed by Hologic, Inc. with the FDA for Digital Spot Mammography System.

Pre-market Notification Details

Device IDK100692
510k NumberK100692
Device Name:DIGITAL SPOT MAMMOGRAPHY SYSTEM
ClassificationSystem, X-ray, Mammographic
Applicant HOLOGIC, INC. 36 APPLE RIDGE ROAD Danbury,  CT  06810
ContactGail Yaeker-daunis
CorrespondentGail Yaeker-daunis
HOLOGIC, INC. 36 APPLE RIDGE ROAD Danbury,  CT  06810
Product CodeIZH  
CFR Regulation Number892.1710 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-03-10
Decision Date2010-04-06

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
15420045506077 K100692 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.