Medical Device Manufacturer · NL , Rotterdam

Quantib B.V. - FDA 510(k) Cleared Devices

11 submissions · 11 cleared · Since 2016

Recent clearances: DeepHealth ProstateAI, Brain WMH, Quantib Prostate

11

Total

11

Cleared

0

Denied

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

11 devices

1-11 of 11

Cleared Apr 29, 2026

DeepHealth ProstateAI

Radiology · 159d

Cleared Sep 25, 2025

Radiology · 129d

Cleared Apr 17, 2023

Quantib Prostate

Radiology · 27d

Cleared May 13, 2022

Quantib Prostate

Radiology · 28d

Cleared Jan 14, 2022

Radiology · 46d

Cleared Oct 11, 2020

Quantib Prostate

Radiology · 41d

Cleared Jun 15, 2020

Quantib AI Node

Radiology · 73d

Cleared Dec 27, 2018

Radiology · 100d

Cleared Mar 09, 2018

Radiology · 73d

Cleared Jan 06, 2017

Quantib Brain 1.2

Radiology · 70d

Cleared Jun 17, 2016

Quantib Brain 1

Radiology · 210d