Echosens 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
FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630)510(k)Mar 2, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Mar 2, 2023
FibroScan 230510(k)Jul 30, 2021Radiology	Radiology	510(k)Substantially Equivalent (Special)	Jul 30, 2021
FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630)510(k)Mar 25, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Mar 25, 2021