Data / Medical devices / Israel / Magentiq Eye Ltd
Magentiq Eye Ltd: FDA-registered device maker in Haifa, Israel, 1 510(k) clearance
Magentiq Eye Ltd is registered with the FDA (registration 3030626336) in Haifa, Israel. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated July 25, 2023. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3030626336
- Address
- 6 Ben-Gurion Blvd., Haifa, Israel, 3541416
- Owner or operator
- Magentiq Eye Ltd (10090333)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- March 13, 2024
- Registered through
- 2026
- Brand names listed
- MAGENTIQ-COLO, ME-APDS
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Gastrointesinal Lesion Software Detection System | QNP | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 25, 2023 | K223473 | ME-APDS; MAGENTIQ-COLO | QNP | Substantially Equivalent | Magentiq Eye, Ltd. | accessdata.fda.gov |
Compare with other makers
Updated July 25, 2023. 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.