Sonio 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
Sonio Suspect510(k)Jun 4, 2026Radiology	Radiology	510(k)Substantially Equivalent (Special)	Jun 4, 2026
Sonio Detect (v3)510(k)Mar 16, 2026Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Mar 16, 2026
Sonio Suspect510(k)Feb 21, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Feb 21, 2025
Sonio Detect510(k)Apr 26, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Apr 26, 2024
Sonio Detect510(k)Jul 25, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jul 25, 2023