Company profile

Therapixel

Therapixel has 7 AI-enabled medical devices on the FDA list. The first decision was on March 25, 2020 and the most recent on June 26, 2026 (MammoScreen® (5)). Its most common review panel is Radiology (7 devices).

7AI devices

2020First decision

2026Latest decision

1Specialties

Per year

20202021202420252026

Therapixel AI devices per year: 2020 1, 2021 1, 2024 2, 2025 2, 2026 1

By specialty

Radiology7

Related guides

Top radiology devices

Timeline

June 26, 2026 · 510(k) K260714MammoScreen® (5) · Radiology · QDQ
August 22, 2025 · 510(k) K243685MammoScreen BD · Radiology · QIH
July 3, 2025 · 510(k) K243679MammoScreen® (4) · Radiology · QDQ
October 2, 2024 · 510(k) K241561MammoScreen BD · Radiology · QIH
August 1, 2024 · 510(k) K240301MammoScreen® (3) · Radiology · QDQ
November 26, 2021 · 510(k) K211541MammoScreen 2.0 · Radiology · QDQ
March 25, 2020 · 510(k) K192854MammoScreen · Radiology · QDQ