Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Rayence Co., Ltd. — Predicate Candidate Screening
39 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
36 daysmedian FDA review time
132 days90th percentile
39clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253800 | 0909FCE, 0909FCE-HS | Rayence Co., Ltd. | 2026-07-31 | 245 | 0 |
| K243849 | 2430TCA with Xmaru W | Rayence Co., Ltd. | 2025-03-12 | 86 | 0 |
| K242394 | Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717 | Rayence Co., Ltd. | 2024-09-09 | 27 | 0 |
| K240371 | 0909FCC, 0909FCC-HS | Rayence Co., Ltd. | 2024-03-07 | 29 | 0 |
| K231467 | 1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF | Rayence Co., Ltd. | 2023-06-21 | 30 | 0 |
| K220689 | Vatech Clismile | Rayence Co., Ltd. | 2022-05-06 | 58 | 0 |
| K212753 | 0909FCB, 1212FCA | Rayence Co., Ltd. | 2021-10-18 | 48 | 0 |
| K202902 | 2430MCA with Xmaru W | Rayence Co., Ltd. | 2021-06-21 | 265 | 0 |
| K210985 | 1717FCC | Rayence Co., Ltd. | 2021-04-28 | 27 | 0 |
| K202722 | 1212FCA | Rayence Co., Ltd. | 2020-10-26 | 39 | 0 |
| K201796 | 1717SCV, 1717SGV | Rayence Co., Ltd. | 2020-07-23 | 23 | 0 |
| K190866 | XmaruView V1 (Xmaru Chiroview, Xmaru Podview) | Rayence Co., Ltd. | 2019-04-30 | 27 | 0 |
| K183478 | ClearON Mobile | Rayence Co., Ltd. | 2019-03-01 | 74 | 0 |
| K171418 | 1417WCC_127um and1417WCC_140um | Rayence Co., Ltd. | 2017-06-12 | 28 | 0 |
| K171417 | 1417WGC_127um and 1417WGC_140um | Rayence Co., Ltd. | 2017-06-12 | 28 | 0 |
| K171419 | 1717SGC_127um and 1717SGC_140um | Rayence Co., Ltd. | 2017-06-09 | 25 | 0 |
| K171420 | 1717SCC_127um and 1717SCC_140um | Rayence Co., Ltd. | 2017-06-09 | 25 | 0 |
| K162519 | 1717WCC / 1717WGC | Rayence Co., Ltd. | 2016-10-06 | 27 | 0 |
| K162518 | 1012WCC, 1012WGC | Rayence Co., Ltd. | 2016-10-06 | 27 | 0 |
| K160579 | Xmaru View V1 and Xmaru PACS, Medical Image Processing Softw | Rayence Co., Ltd. | 2016-04-08 | 38 | 0 |
| K153060 | Digital Dental Intra Oral Sensor, EzSensor Classic, EzSensor | Rayence Co., Ltd. | 2015-11-10 | 20 | 0 |
| K151707 | EzSensor Soft, EzSensor Soft i, EzSensor Bio, and EzSensor B | Rayence Co., Ltd. | 2015-07-19 | 25 | 0 |
| K150797 | Digital Dental Intra Oral Sensor, EzSensor Smart | Rayence Co., Ltd. | 2015-05-01 | 36 | 0 |
| K150150 | 1717SGN / 1717SCN Digital Flat Panel X-ray Detector | Rayence Co., Ltd. | 2015-03-27 | 63 | 0 |
| K143753 | Digital Dental Intra Oral Sensor, EzSensor Soft, EzSensor Bi | Rayence Co., Ltd. | 2015-03-10 | 69 | 0 |
| K141563 | SOLID STATE X-RAY IMAGING DEVICE, DIGITAL FLAT PANEL X-RAY D | Rayence Co., Ltd. | 2014-07-16 | 34 | 0 |
| K141566 | SOLID STATE X-RAY IMAGING DEVICE, DIGIITAL FLAT PANEL X-RAY | Rayence Co., Ltd. | 2014-07-16 | 34 | 0 |
| K140060 | DIGITAL DENTAL INTRA ORAL SENSOR, HDI 2000, HDI 2000A | Rayence Co., Ltd. | 2014-05-13 | 123 | 0 |
| K140056 | DIGITAL DENTAL INTRA ORAL SENSOR; HDI 1000, HDI 1000A | Rayence Co., Ltd. | 2014-05-13 | 123 | 0 |
| K140646 | DIGITAL FLAT PANEL X-RAY DETECTOR / 1717G, XMARU1717G | Rayence Co., Ltd. | 2014-04-11 | 29 | 0 |
| K133409 | DIGITAL FLAT PANEL X-RAY DETECTOR/ 910SGA | Rayence Co., Ltd. | 2014-02-21 | 106 | 0 |
| K131114 | DIGITAL FLAT PANEL X-RAY DETECTOR | Rayence Co., Ltd. | 2013-09-17 | 148 | 0 |
| K130935 | DIGITAL FLAT PANEL X-RAY DETECTOR/1417WCA | Rayence Co., Ltd. | 2013-07-02 | 89 | 0 |
| K123345 | DIGITAL FLAT PANEL X-RAY DETECTOR / 1012WCA | Rayence Co., Ltd. | 2013-03-12 | 132 | 0 |
| K122928 | DIGITAL FLAT PANEL X-RAY DETECTOR/1417PGA | Rayence Co., Ltd. | 2013-01-30 | 128 | 0 |
| K122919 | DIGITAL FLAT PANEL X-RAY DETECTOR11417PCA | Rayence Co., Ltd. | 2013-01-01 | 99 | 0 |
| K122173 | DIGITAL FLAT PLANEL X-RAY DETECTOR / 1717SCC | Rayence Co., Ltd. | 2012-10-19 | 88 | 0 |
| K122182 | DIGITAL FLAT PANEL X-RAY DETECTOR/1717SGC | Rayence Co., Ltd. | 2012-08-16 | 24 | 0 |
| K113630 | DIGITAL FLAT PANEL X-RAY DETECTOR/1210SGA | Rayence Co., Ltd. | 2011-12-29 | 21 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda