Spectrawave, Inc. FDA Approvals

0 new drug approvals and 6 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
HyperVue Imaging System - Integrated510(k)Dec 15, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Dec 15, 2025
X1-FFR510(k)Oct 17, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Oct 17, 2025
HyperVue Software510(k)Jul 16, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jul 16, 2025
Starlight Imaging Catheter510(k)Mar 20, 2025Radiology	Radiology	510(k)Substantially Equivalent (Special)	Mar 20, 2025
HyperVue Imaging System510(k)Jun 7, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jun 7, 2023
SpectraWAVE Imaging System510(k)Feb 28, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Feb 28, 2023