Rayence Co., Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
38
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K2438492430TCA with Xmaru WMarch 12, 2025
K242394Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF)September 9, 2024
K2403710909FCC, 0909FCC-HSMarch 7, 2024
K2314671417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GFJune 21, 2023
K220689Vatech ClismileMay 6, 2022
K2127530909FCB, 1212FCAOctober 18, 2021
K2029022430MCA with Xmaru WJune 21, 2021
K2109851717FCCApril 28, 2021
K2027221212FCAOctober 26, 2020
K2017961717SCV, 1717SGVJuly 23, 2020
K190866XmaruView V1 (Xmaru Chiroview, Xmaru Podview)April 30, 2019
K183478ClearON MobileMarch 1, 2019
K1714181417WCC_127um and1417WCC_140umJune 12, 2017
K1714171417WGC_127um and 1417WGC_140umJune 12, 2017
K1714191717SGC_127um and 1717SGC_140umJune 9, 2017
K1714201717SCC_127um and 1717SCC_140umJune 9, 2017
K1625191717WCC / 1717WGCOctober 6, 2016
K1625181012WCC, 1012WGCOctober 6, 2016
K160579Xmaru View V1 and Xmaru PACS, Medical Image Processing SoftwareApril 8, 2016
K153060Digital Dental Intra Oral Sensor, EzSensor Classic, EzSensor HD, HDI-P, HDI-SNovember 10, 2015