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Iray Technology Taicang , Ltd. FDA Approvals

0 new drug approvals and 13 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
Portable X-ray System510(k)Jan 17, 2023Dental	Dental	510(k)Substantially Equivalent (Traditional)	Jan 17, 2023
Mercu 1717V510(k)Oct 20, 2022Radiology	Radiology	510(k)Substantially Equivalent (Special)	Oct 20, 2022
Flat Panel Detector510(k)Jun 29, 2022Radiology	Radiology	510(k)Substantially Equivalent (Special)	Jun 29, 2022
Wireless Digital Flat Panel Detector510(k)Jun 16, 2022Radiology	Radiology	510(k)Substantially Equivalent (Special)	Jun 16, 2022
Digital flat panel detector510(k)Apr 28, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Apr 28, 2022
Wireless Digital Flat Panel Detector510(k)Apr 1, 2022Radiology	Radiology	510(k)Substantially Equivalent (Special)	Apr 1, 2022
Focus HD 35 Detector510(k)Mar 29, 2022Radiology	Radiology	510(k)Substantially Equivalent (Special)	Mar 29, 2022
Focus HD 43 Detector510(k)Mar 29, 2022Radiology	Radiology	510(k)Substantially Equivalent (Special)	Mar 29, 2022
Dental sensors NanoPix1, NanoPix2510(k)Mar 11, 2022Dental	Dental	510(k)Substantially Equivalent (Special)	Mar 11, 2022
Digital Intraoral X-ray Imaging System510(k)Oct 7, 2021Dental	Dental	510(k)Substantially Equivalent (Traditional)	Oct 7, 2021
PlutoX Digital Intraoral X-Ray Imaging System510(k)Apr 23, 2021Dental	Dental	510(k)Substantially Equivalent (Traditional)	Apr 23, 2021
Mars 1417X Wireless Digital Flat Panel Detector510(k)Mar 3, 2021Radiology	Radiology	510(k)Substantially Equivalent (Special)	Mar 3, 2021
Mars1717X Wireless Digital Flat Panel Detector510(k)Mar 2, 2021Radiology	Radiology	510(k)Substantially Equivalent (Special)	Mar 2, 2021

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