Data / Medical devices / Israel / Image Navigation Ltd
Image Navigation Ltd: FDA-registered device maker in Jerusalem, Israel, 2 510(k) clearances
Image Navigation Ltd is registered with the FDA (registration 3002725845) in Jerusalem, Israel. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated December 16, 2005. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3002725845
- Address
- 17 Hartom st. Har Hotzvim, Jerusalem, Israel, 9777513
- Owner or operator
- Image Navigation Ltd (9053327)
- Roles
- Manufacturer
- First device listed
- December 14, 2007
- Registered through
- 2026
- Brand names listed
- IGI
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Neurological Stereotaxic Instrument | HAW | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| December 16, 2005 | K052840 | IGI-SYSTEM | HAW | Substantially Equivalent | Denx Advanced Dental Systems | accessdata.fda.gov |
| May 9, 2003 | K023424 | IGI-SYSTEM | HAW | Substantially Equivalent | Denx Advanced Dental Systems | accessdata.fda.gov |
Compare with other makers
Updated December 16, 2005. 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.