Data / Medical devices / Gastrointesinal Lesion Software Detection System
Gastrointesinal Lesion Software Detection System (QNP): 11 FDA-registered makers in 5 countries
11 establishments in 5 countries are registered with the FDA to make Gastrointesinal Lesion Software Detection System (product code QNP, Class 2, 21 CFR 876.1520). 7 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 23 510(k) clearances under this code, the latest on September 12, 2026, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- QNP
- Device class
- 2
- Regulation
- 876.1520
- Medical specialty
- Gastroenterology, Urology
Makers by country
| Country | Makers |
|---|---|
| Japan | 6 |
| Italy | 2 |
| United Kingdom | 1 |
| China | 1 |
| Israel | 1 |
Makers of Gastrointesinal Lesion Software Detection System
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Linkverse S.R.L. | Roma, Italy | Manufacturer, Specification developer | 3 | May 29, 2026 | 0 | 0 | 0 | api.fda.gov |
| Odin Medical Limited | London London, City of, United Kingdom | Manufacturer | 3 | September 12, 2026 | 0 | 0 | 0 | api.fda.gov |
| FUJIFILM Healthcare Manufacturing Corporation Hanamaki Office | HANAMAKI-SHI Iwate, Japan | Manufacturer | 2 | August 7, 2026 | 0 | 0 | 0 | api.fda.gov |
| Chengdu Wision Medical Device Co., Ltd. | Chengdu Sichuan, China | Manufacturer | 1 | November 19, 2021 | 0 | 0 | 0 | api.fda.gov |
| Fujifilm Corporation | ASHIGARAKAMI-GUN Kanagawa, Japan | Specification developer | 1 | August 7, 2026 | 0 | 0 | 0 | api.fda.gov |
| FUJIFILM Corporation Medical Systems Research & Development Center Kaisei | Ashigarakami-Gun Kanagawa, Japan | Specification developer | 1 | December 15, 2023 | 0 | 0 | 0 | api.fda.gov |
| Magentiq Eye Ltd | Haifa, Israel | Complaint file establishment, Manufacturer, Specification developer | 1 | July 25, 2023 | 0 | 0 | 0 | api.fda.gov |
| HOYA Corporation PENTAX Lifecare Division | Akishima-shi Tokyo, Japan | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MB Elettronica S.r.l. | Cortona Arezzo, Italy | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Olympus Medical Systems Corp. | HACHIOJI-SHI Tokyo, Japan | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shirakawa Olympus Co., Ltd. | NISHISHIRAKAWA-GUN Fukushima, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated September 12, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.