Company ยท KR
Rayence Co., Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2011 to 2026. Name variants (Inc, Corp, punctuation) are merged.
39510(k) clearances (1 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 31, 2026 | K253800 | 0909FCE, 0909FCE-HS Rayence Co., Ltd., KR | MQB |
| Mar 12, 2025 | K243849 | 2430TCA with Xmaru W Rayence Co., Ltd., KR | MUE |
| Sep 9, 2024 | K242394 | Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF) Rayence Co., Ltd., KR | MQB |
| Mar 7, 2024 | K240371 | 0909FCC, 0909FCC-HS Rayence Co., Ltd., KR | MQB |
| Jun 21, 2023 | K231467 | 1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF Rayence Co., Ltd., KR | MQB |
| May 6, 2022 | K220689 | Vatech Clismile Rayence Co., Ltd., KR | NJM |
| Oct 18, 2021 | K212753 | 0909FCB, 1212FCA Rayence Co., Ltd., KR | MQB |
| Jun 21, 2021 | K202902 | 2430MCA with Xmaru W Rayence Co., Ltd., KR | MUE |
| Apr 28, 2021 | K210985 | 1717FCC Rayence Co., Ltd., KR | MQB |
| Oct 26, 2020 | K202722 | 1212FCA Rayence Co., Ltd., KR | MQB |
| Jul 23, 2020 | K201796 | 1717SCV, 1717SGV Rayence Co., Ltd., KR | MQB |
| Apr 30, 2019 | K190866 | XmaruView V1 (Xmaru Chiroview, Xmaru Podview) Rayence Co., Ltd., KR | LLZ |
| Mar 1, 2019 | K183478 | ClearON Mobile Rayence Co., Ltd., KR | LLZ |
| Jun 12, 2017 | K171418 | 1417WCC_127um and1417WCC_140um Rayence Co., Ltd., KR | MQB |
| Jun 12, 2017 | K171417 | 1417WGC_127um and 1417WGC_140um Rayence Co., Ltd., KR | MQB |
| Jun 9, 2017 | K171420 | 1717SCC_127um and 1717SCC_140um Rayence Co., Ltd., KR | MQB |
| Jun 9, 2017 | K171419 | 1717SGC_127um and 1717SGC_140um Rayence Co., Ltd., KR | MQB |
| Oct 6, 2016 | K162519 | 1717WCC / 1717WGC Rayence Co., Ltd., KR | MQB |
| Oct 6, 2016 | K162518 | 1012WCC, 1012WGC Rayence Co., Ltd., KR | MQB |
| Apr 8, 2016 | K160579 | Xmaru View V1 and Xmaru PACS, Medical Image Processing Software Rayence Co., Ltd., KR | LLZ |
| Nov 10, 2015 | K153060 | Digital Dental Intra Oral Sensor, EzSensor Classic, EzSensor HD, HDI-P, HDI-S Rayence Co., Ltd., KR | MUH |
| Jul 19, 2015 | K151707 | EzSensor Soft, EzSensor Soft i, EzSensor Bio, and EzSensor Bio i Rayence Co., Ltd., KR | MUH |
| May 1, 2015 | K150797 | Digital Dental Intra Oral Sensor, EzSensor Smart Rayence Co., Ltd., KR | MUH |
| Mar 27, 2015 | K150150 | 1717SGN / 1717SCN Digital Flat Panel X-ray Detector Rayence Co., Ltd., KR | MQB |
| Mar 10, 2015 | K143753 | Digital Dental Intra Oral Sensor, EzSensor Soft, EzSensor Bio Rayence Co., Ltd., KR | MUH |
| Jul 16, 2014 | K141566 | SOLID STATE X-RAY IMAGING DEVICE, DIGIITAL FLAT PANEL X-RAY DETECTOR, 1417WCC Rayence Co., Ltd. | MQB |
| Jul 16, 2014 | K141563 | SOLID STATE X-RAY IMAGING DEVICE, DIGITAL FLAT PANEL X-RAY DETECTOR, 1417WGC Rayence Co., Ltd. | MQB |
| May 13, 2014 | K140060 | DIGITAL DENTAL INTRA ORAL SENSOR, HDI 2000, HDI 2000A Rayence Co., Ltd. | MQB |
| May 13, 2014 | K140056 | DIGITAL DENTAL INTRA ORAL SENSOR; HDI 1000, HDI 1000A Rayence Co., Ltd. | MQB |
| Apr 11, 2014 | K140646 | DIGITAL FLAT PANEL X-RAY DETECTOR / 1717G, XMARU1717G Rayence Co., Ltd. | MQB |
| Feb 21, 2014 | K133409 | DIGITAL FLAT PANEL X-RAY DETECTOR/ 910SGA Rayence Co., Ltd. | MQB |
| Sep 17, 2013 | K131114 | DIGITAL FLAT PANEL X-RAY DETECTOR Rayence Co., Ltd. | MQB |
| Jul 2, 2013 | K130935 | DIGITAL FLAT PANEL X-RAY DETECTOR/1417WCA Rayence Co., Ltd. | MQB |
| Mar 12, 2013 | K123345 | DIGITAL FLAT PANEL X-RAY DETECTOR / 1012WCA Rayence Co., Ltd. | MQB |
| Jan 30, 2013 | K122928 | DIGITAL FLAT PANEL X-RAY DETECTOR/1417PGA Rayence Co., Ltd. | MQB |
| Jan 1, 2013 | K122919 | DIGITAL FLAT PANEL X-RAY DETECTOR11417PCA Rayence Co., Ltd. | MQB |
| Oct 19, 2012 | K122173 | DIGITAL FLAT PLANEL X-RAY DETECTOR / 1717SCC Rayence Co., Ltd. | MQB |
| Aug 16, 2012 | K122182 | DIGITAL FLAT PANEL X-RAY DETECTOR/1717SGC Rayence Co., Ltd. | MQB |
| Dec 29, 2011 | K113630 | DIGITAL FLAT PANEL X-RAY DETECTOR/1210SGA Rayence Co., Ltd. | MQB |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||