Affirm Prone Biopsy System

System, X-ray, Mammographic

Hologic Inc

The following data is part of a premarket notification filed by Hologic Inc with the FDA for Affirm Prone Biopsy System.

Pre-market Notification Details

Device IDK153486
510k NumberK153486
Device Name:Affirm Prone Biopsy System
ClassificationSystem, X-ray, Mammographic
Applicant Hologic Inc 36 Apple Ridge Road Danbury,  CT  06810
ContactSarah Fairfield
CorrespondentSarah Fairfield
Hologic, Inc 36 Apple Ridge Rd. Danbury,  CT  06810
Product CodeIZH  
CFR Regulation Number892.1710 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-12-04
Decision Date2016-04-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
15420045506541 K153486 000
15420045510852 K153486 000
15420045510869 K153486 000
15420045504721 K153486 000
15420045504738 K153486 000
15420045506466 K153486 000
15420045506473 K153486 000
15420045506480 K153486 000
15420045506497 K153486 000
15420045506503 K153486 000
15420045506510 K153486 000
15420045506527 K153486 000
15420045506534 K153486 000
15420045510845 K153486 000

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