Medical Device Manufacturer · NL , Nijmegen

Screenpoint Medical B.V. - FDA 510(k) Cleared Devices

8 submissions · 8 cleared · Since 2018

Recent clearances: Transpara (2.1.0), Transpara (2.1.0), Transpara Density 1.0.0

8

Total

8

Cleared

0

Denied

FDA 510(k) Regulatory Record - Screenpoint Medical B.V. Radiology ✕

8 devices

1-8 of 8

Cleared Aug 14, 2026

Transpara (2.1.0)

Radiology · 149d

Cleared Nov 25, 2024

Transpara (2.1.0)

Radiology · 153d

Cleared Dec 11, 2023

Transpara Density 1.0.0

Radiology · 151d

Cleared Aug 03, 2022

Transpara 1.7.2

Radiology · 86d

Cleared Jun 02, 2021

Transpara 1.7.0

Radiology · 112d

Cleared Mar 05, 2020

Radiology · 104d

Cleared Dec 10, 2019

Radiology · 110d

Cleared Nov 21, 2018

Radiology · 147d