Genoray Co., Ltd.: FDA filings under this applicant name
FDA lists 24 510(k) clearances under the applicant name “Genoray Co., Ltd.” (first 2007, latest 2026), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 178 days. Since 2017 the median was 170 days, against 116 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 | 1 | 162 |
| 2013 | 2 | 222 |
| 2014 | 2 | 226 |
| 2015 | 1 | 302 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 3 | 170 |
| 2019 | 0 | — |
| 2020 | 1 | 203 |
| 2021 | 0 | — |
| 2022 | 3 | 97 |
| 2023 | 3 | 120 |
| 2024 | 0 | — |
| 2025 | 2 | 263 |
| 2026 | 1 | 260 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Genoray Co., Ltd. took a median 170 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 116 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MUH | System, X-Ray, Extraoral Source, Digital | 7 | 7 |
| OWB | Interventional Fluoroscopic X-Ray System | 7 | 7 |
| OAS | X-Ray, Tomography, Computed, Dental | 4 | 4 |
| EHD | Unit, X-Ray, Extraoral With Timer | 3 | 3 |
| LLZ | System, Image Processing, Radiological | 2 | 2 |
| MUE | Full Field Digital, System, X-Ray, Mammographic | 1 | 1 |
Review panels
- Radiology (24)
Most recent Genoray Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252229 | BELLIGER ACE | OWB | 2026-04-02 | 260 |
| K250060 | GT300; GT300-C | OAS | 2025-10-08 | 271 |
| K243420 | HESTIA | MUE | 2025-07-17 | 255 |
| K232085 | DVAS (DVAS-M, DVAS-W) | EHD | 2023-12-08 | 148 |
| K232158 | GenX-CR | MUH | 2023-09-13 | 55 |
| K230787 | Oscar 15 & Oscar 15i | OWB | 2023-07-20 | 120 |
| K220423 | PAPAYA & PAPAYA Plus | MUH | 2022-05-19 | 94 |
| K220392 | PAPAYA 3D & PAPAYA 3D Plus | OAS | 2022-05-19 | 97 |
| K211780 | ZEN-2090 Turbo | OWB | 2022-03-09 | 273 |
| K200469 | PAPAYA 3D Premium & PAPAYA 3D Premium Plus | OAS | 2020-09-16 | 203 |
14 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Genoray 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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Genoray America, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Genoray Co., Ltd.?
FDA lists 24 510(k) clearances under the applicant name “Genoray Co., Ltd.” (first 2007, latest 2026), across 6 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Genoray Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Genoray Co., Ltd. is 178 days. Since 2017: 170 days, versus 116 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Genoray Co., Ltd.?
The most frequent FDA product codes under this applicant name are MUH (System, X-Ray, Extraoral Source, Digital, 7); OWB (Interventional Fluoroscopic X-Ray System, 7); OAS (X-Ray, Tomography, Computed, Dental, 4).
Next steps
- See all 24 Genoray Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code MUH, Genoray 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.