Quantib B.V. FDA Approvals

0 new drug approvals and 5 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
DeepHealth ProstateAI510(k)Apr 29, 2026Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Apr 29, 2026
Brain WMH510(k)Sep 25, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Sep 25, 2025
Quantib Prostate510(k)Apr 17, 2023Radiology	Radiology	510(k)Substantially Equivalent (Special)	Apr 17, 2023
Quantib Prostate510(k)May 13, 2022Radiology	Radiology	510(k)Substantially Equivalent (Special)	May 13, 2022
Quantib ND510(k)Jan 14, 2022Radiology	Radiology	510(k)Substantially Equivalent (Special)	Jan 14, 2022