Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) 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
Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000Exp/ Apogee 1000B/W / Apogee 1U/ Apogee 1T/ Apogee 1G Digital Color Doppler Ultrasound Imaging System510(k)Aug 19, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Aug 19, 2021
Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging System510(k)Aug 18, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Aug 18, 2021
SR-1000 Portable DR Imaging System, SR-1000S Portable DR Imaging System510(k)Jan 6, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jan 6, 2021