Company profile

Hologic, Inc.

Hologic, Inc. has 9 AI-enabled medical devices on the FDA list. The first decision was on June 26, 1998 and the most recent on July 31, 2025 (Genius AI Detection 2.0). Its most common review panel is Radiology (8 devices).

9AI devices

1998First decision

2025Latest decision

2Specialties

Per year

199820082014201720202022202320242025

Hologic, Inc. AI devices per year: 1998 1, 2008 1, 2014 1, 2017 1, 2020 1, 2022 1, 2023 1, 2024 1, 2025 1

By specialty

Radiology8
Pathology1

Related guides

Top radiology devices

Timeline

July 31, 2025 · 510(k) K243341Genius AI Detection 2.0 · Radiology · QDQ
January 31, 2024 · De Novo DEN210035Genius Digital Diagnostics System with the Genius Cervical AI algorithm · Pathology · QYV
May 23, 2023 · 510(k) K230096Genius AI Detection 2.0 with CC-MLO Correlation · Radiology · QDQ
October 6, 2022 · 510(k) K221449Genius AI Detection 2.0 · Radiology · QDQ
November 18, 2020 · 510(k) K201019Genius AI Detection · Radiology · QDQ
October 20, 2017 · 510(k) K163623Quantra · Radiology · LLZ
October 10, 2014 · 510(k) K142037QUANTRA · Radiology · LLZ
September 12, 2008 · 510(k) K082483QUANTRA · Radiology · LLZ
June 26, 1998 · PMA P970058M1000 IMAGECHECKER · Radiology · MYN