Radmedix, LLC 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
AcuityUDR510(k)Oct 25, 2023Radiology	Radiology	510(k)Substantially Equivalent (Abbreviated)	Oct 25, 2023
AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4510(k)Jul 12, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jul 12, 2023
AcuityDRe510(k)Apr 30, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Apr 30, 2021