FDA 510(k) Applications Submitted by RAYENCE CO., LTD
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K140056 |
01/10/2014 |
DIGITAL DENTAL INTRA ORAL SENSOR; HDI 1000, HDI 1000A |
RAYENCE CO., LTD |
| K140060 |
01/10/2014 |
DIGITAL DENTAL INTRA ORAL SENSOR, HDI 2000, HDI 2000A |
RAYENCE CO., LTD |
| K140646 |
03/13/2014 |
DIGITAL FLAT PANEL X-RAY DETECTOR / 1717G, XMARU1717G |
RAYENCE CO., LTD |
| K130935 |
04/04/2013 |
DIGITAL FLAT PANEL X-RAY DETECTOR/1417WCA |
RAYENCE CO., LTD |
| K131114 |
04/22/2013 |
DIGITAL FLAT PANEL X-RAY DETECTOR |
RAYENCE CO., LTD |
| K141563 |
06/12/2014 |
SOLID STATE X-RAY IMAGING DEVICE, DIGITAL FLAT PANEL X-RAY DETECTOR, 1417WGC |
RAYENCE CO., LTD |
| K141566 |
06/12/2014 |
SOLID STATE X-RAY IMAGING DEVICE, DIGIITAL FLAT PANEL X-RAY DETECTOR, 1417WCC |
RAYENCE CO., LTD |
| K122173 |
07/23/2012 |
DIGITAL FLAT PLANEL X-RAY DETECTOR / 1717SCC |
RAYENCE CO., LTD |
| K122182 |
07/23/2012 |
DIGITAL FLAT PANEL X-RAY DETECTOR/1717SGC |
RAYENCE CO., LTD |
| K122919 |
09/24/2012 |
DIGITAL FLAT PANEL X-RAY DETECTOR11417PCA |
RAYENCE CO., LTD |
| K122928 |
09/24/2012 |
DIGITAL FLAT PANEL X-RAY DETECTOR/1417PGA |
RAYENCE CO., LTD |
| K123345 |
10/31/2012 |
DIGITAL FLAT PANEL X-RAY DETECTOR / 1012WCA |
RAYENCE CO., LTD |
| K133409 |
11/07/2013 |
DIGITAL FLAT PANEL X-RAY DETECTOR/ 910SGA |
RAYENCE CO., LTD |
| K113630 |
12/08/2011 |
DIGITAL FLAT PANEL X-RAY DETECTOR/1210SGA |
RAYENCE CO., LTD |
| K202722 |
09/17/2020 |
1212FCA |
Rayence Co., Ltd |
| K202902 |
09/29/2020 |
2430MCA with Xmaru W |
Rayence Co., Ltd |
| K150150 |
01/23/2015 |
1717SGN / 1717SCN Digital Flat Panel X-ray Detector |
Rayence Co., Ltd |
| K160579 |
03/01/2016 |
Xmaru View V1 and Xmaru PACS, Medical Image Processing Software |
RAYENCE CO., LTD |
| K150797 |
03/26/2015 |
Digital Dental Intra Oral Sensor, EzSensor Smart |
Rayence Co., Ltd |
| K210985 |
04/01/2021 |
1717FCC |
Rayence Co., Ltd |
| K190866 |
04/03/2019 |
XmaruView V1 (Xmaru Chiroview, Xmaru Podview) |
Rayence Co., Ltd |
| K171417 |
05/15/2017 |
1417WGC_127um and 1417WGC_140um |
Rayence Co., Ltd |
| K171418 |
05/15/2017 |
1417WCC_127um and1417WCC_140um |
Rayence Co., Ltd |
| K171419 |
05/15/2017 |
1717SGC_127um and 1717SGC_140um |
Rayence Co., Ltd |
| K171420 |
05/15/2017 |
1717SCC_127um and 1717SCC_140um |
Rayence Co., Ltd |
| K231467 |
05/22/2023 |
1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF |
Rayence Co., Ltd |
| K151707 |
06/24/2015 |
EzSensor Soft, EzSensor Soft i, EzSensor Bio, and EzSensor Bio i |
RAYENCE CO., LTD |
| K212753 |
08/31/2021 |
0909FCB, 1212FCA |
Rayence Co., Ltd |
| K162519 |
09/09/2016 |
1717WCC / 1717WGC |
RAYENCE CO., LTD |
| K153060 |
10/21/2015 |
Digital Dental Intra Oral Sensor, EzSensor Classic, EzSensor HD, HDI-P, HDI-S |
RAYENCE CO., LTD |
| K143753 |
12/31/2014 |
Digital Dental Intra Oral Sensor, EzSensor Soft, EzSensor Bio |
Rayence Co., Ltd |
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