Company profile

ScreenPoint Medical B.V.

ScreenPoint Medical B.V. has 7 AI-enabled medical devices on the FDA list. The first decision was on November 21, 2018 and the most recent on November 25, 2024 (Transpara (2.1.0)). Its most common review panel is Radiology (7 devices).

7AI devices

2018First decision

2024Latest decision

1Specialties

Per year

2018201920202021202220232024

ScreenPoint Medical B.V. AI devices per year: 2018 1, 2019 1, 2020 1, 2021 1, 2022 1, 2023 1, 2024 1

By specialty

Radiology7

Related guides

Top radiology devices

Timeline

November 25, 2024 · 510(k) K241831Transpara (2.1.0) · Radiology · QDQ
December 11, 2023 · 510(k) K232096Transpara Density 1.0.0 · Radiology · QIH
August 3, 2022 · 510(k) K221347Transpara 1.7.2 · Radiology · QDQ
June 2, 2021 · 510(k) K210404Transpara 1.7.0 · Radiology · QDQ
March 5, 2020 · 510(k) K193229Transpara · Radiology · QDQ
December 10, 2019 · 510(k) K192287Transpara · Radiology · QDQ
November 21, 2018 · 510(k) K181704Transpara · Radiology · QDQ