Supersonic Imagine FDA Approvals

0 new drug approvals and 3 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
SuperSonic HepaVu510(k)Sep 20, 2024Radiology	Radiology	510(k)Substantially Equivalent (Special)	Sep 20, 2024
Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC MACH40510(k)Oct 28, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Oct 28, 2022
Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC MACH40510(k)Jun 29, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jun 29, 2021