Rayence Co., Ltd. FDA Approvals

0 new drug approvals and 9 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
0909FCE, 0909FCE-HS510(k)Jul 31, 2026Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jul 31, 2026
2430TCA with Xmaru W510(k)Mar 12, 2025Radiology	Radiology	510(k)Substantially Equivalent (Special)	Mar 12, 2025
Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF)510(k)Sep 9, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Sep 9, 2024
0909FCC, 0909FCC-HS510(k)Mar 7, 2024Radiology	Radiology	510(k)Substantially Equivalent (Special)	Mar 7, 2024
1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF510(k)Jun 21, 2023Radiology	Radiology	510(k)Substantially Equivalent (Special)	Jun 21, 2023
Vatech Clismile510(k)May 6, 2022Dental	Dental	510(k)Substantially Equivalent (Traditional)	May 6, 2022
0909FCB, 1212FCA510(k)Oct 18, 2021Radiology	Radiology	510(k)Substantially Equivalent (Special)	Oct 18, 2021
2430MCA with Xmaru W510(k)Jun 21, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jun 21, 2021
1717FCC510(k)Apr 28, 2021Radiology	Radiology	510(k)Substantially Equivalent (Special)	Apr 28, 2021