Medical Device Manufacturer · US , Houston , TX

Rayence Co., Ltd.

38 submissions · 38 cleared · Since 2011
38
Total
38
Cleared
0
Denied

Rayence Co., Ltd. — FDA 510(k) Submissions

Rayence Co., Ltd. has submitted 38 FDA 510(k) premarket notifications since 2011, of which 38 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Solid State X-ray Imager (flat Panel/digital Imager), System, X-ray, Extraoral Source, Digital, System, Image Processing, Radiological, Full Field Digital, System, X-ray, Mammographic, Bracket, Ceramic, Orthodontic . Use the specialty filter in the sidebar to narrow results.

38 devices
1–25 of 38
2430TCA with Xmaru W
K243849 · MUE Full Field Digital,... · Radiology
Mar 2025 86d
Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF)
K242394 · MQB Solid State X-ray Imager... · Radiology
Sep 2024 27d
0909FCC, 0909FCC-HS
K240371 · MQB Solid State X-ray Imager... · Radiology
Mar 2024 29d
1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF
K231467 · MQB Solid State X-ray Imager... · Radiology
Jun 2023 30d
Vatech Clismile
K220689 · NJM Bracket, Ceramic,... · Dental
May 2022 58d
0909FCB, 1212FCA
K212753 · MQB Solid State X-ray Imager... · Radiology
Oct 2021 48d
2430MCA with Xmaru W
K202902 · MUE Full Field Digital,... · Radiology
Jun 2021 265d
1717FCC
K210985 · MQB Solid State X-ray Imager... · Radiology
Apr 2021 27d
1212FCA
K202722 · MQB Solid State X-ray Imager... · Radiology
Oct 2020 39d
1717SCV, 1717SGV
K201796 · MQB Solid State X-ray Imager... · Radiology
Jul 2020 23d
XmaruView V1 (Xmaru Chiroview, Xmaru Podview)
K190866 · LLZ System, Image Processing,... · Radiology
Apr 2019 27d
ClearON Mobile
K183478 · LLZ System, Image Processing,... · Radiology
Mar 2019 74d
1417WGC_127um and 1417WGC_140um
K171417 · MQB Solid State X-ray Imager... · Radiology
Jun 2017 28d
1417WCC_127um and1417WCC_140um
K171418 · MQB Solid State X-ray Imager... · Radiology
Jun 2017 28d
1717SGC_127um and 1717SGC_140um
K171419 · MQB Solid State X-ray Imager... · Radiology
Jun 2017 25d
1717SCC_127um and 1717SCC_140um
K171420 · MQB Solid State X-ray Imager... · Radiology
Jun 2017 25d
1012WCC, 1012WGC
K162518 · MQB Solid State X-ray Imager... · Radiology
Oct 2016 27d
1717WCC / 1717WGC
K162519 · MQB Solid State X-ray Imager... · Radiology
Oct 2016 27d
Xmaru View V1 and Xmaru PACS, Medical Image Processing Software
K160579 · LLZ System, Image Processing,... · Radiology
Apr 2016 38d
Digital Dental Intra Oral Sensor, EzSensor Classic, EzSensor HD, HDI-P, HDI-S
K153060 · MUH System, X-ray, Extraoral... · Radiology
Nov 2015 20d
EzSensor Soft, EzSensor Soft i, EzSensor Bio, and EzSensor Bio i
K151707 · MUH System, X-ray, Extraoral... · Radiology
Jul 2015 25d
Digital Dental Intra Oral Sensor, EzSensor Smart
K150797 · MUH System, X-ray, Extraoral... · Radiology
May 2015 36d
1717SGN / 1717SCN Digital Flat Panel X-ray Detector
K150150 · MQB Solid State X-ray Imager... · Radiology
Mar 2015 63d
Digital Dental Intra Oral Sensor, EzSensor Soft, EzSensor Bio
K143753 · MUH System, X-ray, Extraoral... · Radiology
Mar 2015 69d
SOLID STATE X-RAY IMAGING DEVICE, DIGITAL FLAT PANEL X-RAY DETECTOR, 1417WGC
K141563 · MQB Solid State X-ray Imager... · Radiology
Jul 2014 34d
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