Rayence Co., Ltd.: FDA filings under this applicant name
FDA lists 39 510(k) clearances under the applicant name “Rayence Co., Ltd.” (first 2011, latest 2026), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 36 days. Since 2017 the median was 29 days, against 105 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 56 |
| 2013 | 5 | 128 |
| 2014 | 6 | 70 |
| 2015 | 5 | 36 |
| 2016 | 3 | 27 |
| 2017 | 4 | 26 |
| 2018 | 0 | — |
| 2019 | 2 | 50 |
| 2020 | 2 | 31 |
| 2021 | 3 | 48 |
| 2022 | 1 | 58 |
| 2023 | 1 | 30 |
| 2024 | 2 | 28 |
| 2025 | 1 | 86 |
| 2026 | 1 | 245 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Rayence Co., Ltd. took a median 29 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 105 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 29 | 29 |
| MUH | System, X-Ray, Extraoral Source, Digital | 4 | 4 |
| LLZ | System, Image Processing, Radiological | 3 | 3 |
| MUE | Full Field Digital, System, X-Ray, Mammographic | 2 | 2 |
| NJM | Bracket, Ceramic, Orthodontic | 1 | 1 |
Review panels
Most recent Rayence Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253800 | 0909FCE, 0909FCE-HS | MQB | 2026-07-31 | 245 |
| K243849 | 2430TCA with Xmaru W | MUE | 2025-03-12 | 86 |
| K242394 | Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF) | MQB | 2024-09-09 | 27 |
| K240371 | 0909FCC, 0909FCC-HS | MQB | 2024-03-07 | 29 |
| K231467 | 1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF | MQB | 2023-06-21 | 30 |
| K220689 | Vatech Clismile | NJM | 2022-05-06 | 58 |
| K212753 | 0909FCB, 1212FCA | MQB | 2021-10-18 | 48 |
| K202902 | 2430MCA with Xmaru W | MUE | 2021-06-21 | 265 |
| K210985 | 1717FCC | MQB | 2021-04-28 | 27 |
| K202722 | 1212FCA | MQB | 2020-10-26 | 39 |
29 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Rayence Co., Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Rayence Co., Ltd.?
FDA lists 39 510(k) clearances under the applicant name “Rayence Co., Ltd.” (first 2011, latest 2026), across 5 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Rayence Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Rayence Co., Ltd. is 36 days. Since 2017: 29 days, versus 105 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Rayence Co., Ltd.?
The most frequent FDA product codes under this applicant name are MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager), 29); MUH (System, X-Ray, Extraoral Source, Digital, 4); LLZ (System, Image Processing, Radiological, 3).
Next steps
- See all 39 Rayence Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code MQB, Rayence Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.