Medical Device Manufacturer · NL , Rotterdam

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

11 submissions · 11 cleared · Since 2016
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
K253682 · QDQ
Radiology · 159d
Cleared Sep 25, 2025
Brain WMH
K251527 · QIH
Radiology · 129d
Cleared Apr 17, 2023
Quantib Prostate
K230772 · LLZ
Radiology · 27d
Cleared May 13, 2022
Quantib Prostate
K221106 · LLZ
Radiology · 28d
Cleared Jan 14, 2022
Quantib ND
K213737 · LLZ
Radiology · 46d
Cleared Oct 11, 2020
Quantib Prostate
K202501 · LLZ
Radiology · 41d
Cleared Jun 15, 2020
Quantib AI Node
K200899 · LLZ
Radiology · 73d
Cleared Dec 27, 2018
Quantib ND
K182564 · LLZ
Radiology · 100d
Cleared Mar 09, 2018
Quantib Brain
K173939 · LLZ
Radiology · 73d
Cleared Jan 06, 2017
Quantib Brain 1.2
K163013 · LLZ
Radiology · 70d
Cleared Jun 17, 2016
Quantib Brain 1
K153351 · LLZ
Radiology · 210d
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