Aspen Imaging Healthcare, Inc. FDA Approvals

0 new drug approvals and 2 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
AspenView510(k)Feb 12, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Feb 12, 2025
IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector)510(k)Nov 7, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Nov 7, 2024