Arineta , Ltd. FDA Approvals

0 new drug approvals and 4 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
SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option510(k)Apr 15, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Apr 15, 2025
SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening Option510(k)Jan 13, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jan 13, 2025
SpotLight/SpotLight Duo (with DLIR option)510(k)Oct 13, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Oct 13, 2023
CardioGraphe510(k)Dec 2, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Dec 2, 2022