Surgical Information Sciences, Inc. 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
SIS System510(k)Jun 14, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jun 14, 2024
SIS System510(k)May 2, 2023Radiology	Radiology	510(k)Substantially Equivalent (Special)	May 2, 2023
SIS System (Version 5.6.0)510(k)Nov 21, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Nov 21, 2022
SIS System (Version 5.1.0)510(k)Mar 31, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Mar 31, 2021