Medical Device Manufacturer · US , Waltham , MA

Hologic, Inc. - FDA 510(k) Cleared Devices

115 submissions · 111 cleared · Since 1987

Official Website

115

Total

111

Cleared

2

Denied

FDA 510(k) cleared devices by Hologic, Inc. Radiology ✕

62 devices

1-12 of 62

Cleared Jul 31, 2025

Genius AI Detection 2.0

Radiology · 279d

Cleared May 23, 2023

Genius AI Detection 2.0 with CC-MLO Correlation

Radiology · 130d

Cleared Oct 06, 2022

Genius AI Detection 2.0

Radiology · 141d

Cleared Nov 18, 2020

Genius AI Detection

Radiology · 215d

Cleared Oct 05, 2020

Affirm Contrast Biopsy

Radiology · 53d

Cleared Jul 11, 2019

Unifi Workspace v1.0.0

Radiology · 115d

Cleared Jan 10, 2019

Trident HD Specimen Radiography System

Radiology · 104d

Cleared Oct 20, 2017

Radiology · 302d

Cleared Apr 01, 2016

Affirm Prone Biopsy System

Radiology · 119d

Cleared Oct 10, 2014

Radiology · 74d

Cleared Jun 13, 2014

PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM

Radiology · 59d

Cleared Oct 30, 2013

Radiology · 97d

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