Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Genoray Co., Ltd. — Predicate Candidate Screening
24 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
185 daysmedian FDA review time
302 days90th percentile
24clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252229 | BELLIGER ACE | Genoray Co., Ltd. | 2026-04-02 | 260 | 0 |
| K250060 | GT300; GT300-C | Genoray Co., Ltd. | 2025-10-08 | 271 | 0 |
| K243420 | HESTIA | Genoray Co., Ltd. | 2025-07-17 | 255 | 0 |
| K232085 | DVAS (DVAS-M, DVAS-W) | Genoray Co., Ltd. | 2023-12-08 | 148 | 0 |
| K232158 | GenX-CR | Genoray Co., Ltd. | 2023-09-13 | 55 | 0 |
| K230787 | Oscar 15 & Oscar 15i | Genoray Co., Ltd. | 2023-07-20 | 120 | 0 |
| K220423 | PAPAYA & PAPAYA Plus | Genoray Co., Ltd. | 2022-05-19 | 94 | 0 |
| K220392 | PAPAYA 3D & PAPAYA 3D Plus | Genoray Co., Ltd. | 2022-05-19 | 97 | 0 |
| K211780 | ZEN-2090 Turbo | Genoray Co., Ltd. | 2022-03-09 | 273 | 0 |
| K200469 | PAPAYA 3D Premium & PAPAYA 3D Premium Plus | Genoray Co., Ltd. | 2020-09-16 | 203 | 0 |
| K181943 | OSCAR (OSCAR Prime, OSCAR Classic) | Genoray Co., Ltd. | 2018-08-17 | 28 | 0 |
| K172810 | PORT-X IV | Genoray Co., Ltd. | 2018-03-07 | 170 | 0 |
| K172180 | OSCAR 15 | Genoray Co., Ltd. | 2018-02-09 | 205 | 0 |
| K150354 | PAPAYA 3D Plus | Genoray Co., Ltd. | 2015-12-10 | 302 | 0 |
| K140041 | ZEN-7000,SYSTEM,FLUROSCOPIC X-RAY SYSTEM | Genoray Co., Ltd. | 2014-11-28 | 324 | 0 |
| K141700 | PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM | Genoray Co., Ltd. | 2014-10-31 | 129 | 0 |
| K130419 | PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM | Genoray Co., Ltd. | 2013-11-06 | 260 | 0 |
| K130088 | PORT VIEW, DIGITAL X-RAY SENSOR SYSTEM | Genoray Co., Ltd. | 2013-07-18 | 185 | 0 |
| K120263 | VOLUX 21C, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM | Genoray Co., Ltd. | 2012-07-10 | 162 | 0 |
| K103181 | ZENIS, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM | Genoray Co., Ltd. | 2011-08-26 | 302 | 0 |
| K103182 | TRIANA, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM | Genoray Co., Ltd. | 2011-01-14 | 78 | 0 |
| K092171 | VOLUX, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM | Genoray Co., Ltd. | 2010-04-26 | 279 | 0 |
| K091918 | ZEN-2090 PRO, FLUOROSCOPIC X-RAY SYSTEM, MODEL ZEN-2090 PRO | Genoray Co., Ltd. | 2009-10-07 | 99 | 0 |
| K063121 | PORTABLE X-RAY SYSTEM, MODEL PORT-X II | Genoray Co., Ltd. | 2007-01-11 | 91 | 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