Data / Medical devices / Israel / Smart Medical Systems Ltd.
Smart Medical Systems Ltd.: FDA-registered device maker in Raanana Central, Israel, 5 510(k) clearances
Smart Medical Systems Ltd. is registered with the FDA (registration 3005261802) in Raanana Central, Israel. It lists 2 device types. The FDA files 5 510(k) clearances under its listings, the newest dated April 11, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005261802
- Address
- 5 Hanofar Str., Raanana Central, Israel, 4366404
- Owner or operator
- Smart Medical Systems Ltd. (10025066)
- Roles
- Manufacturer
- First device listed
- September 18, 2011
- Registered through
- 2026
- Brand names listed
- G-EYE SYSTEM, G-EYE System, G-EYE Systems, NAVIAID ICVI-F,S,B,R DEVICE, NaviAid¿ ABC Disposable, NaviAid¿ ABC Operation Kit, NaviAid¿ BGC Disposable, NaviAid¿ BGC Operation Kit and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Colonoscope And Accessories, Flexible/Rigid | FDF | 2 | Manufacturer | accessdata.fda.gov |
| Endoscope Channel Accessory | ODC | 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 |
|---|---|---|---|---|---|---|
| April 11, 2022 | K220158 | G-EYE System | FDF | Substantially Equivalent | Smart Medical Systems , Ltd. | accessdata.fda.gov |
| October 26, 2020 | K202469 | G-EYE System | FDF | Substantially Equivalent | Smart Medical Systems , Ltd. | accessdata.fda.gov |
| April 15, 2020 | K192588 | G-EYE System | FDF | Substantially Equivalent | Smart Medical Systems , Ltd. | accessdata.fda.gov |
| February 6, 2012 | K112106 | NAVIAID ICVI-F,S,B,R DEVICE | ODC | Substantially Equivalent | Smart Medical Systems , Ltd. | accessdata.fda.gov |
| August 9, 2011 | K111760 | NAVIAID(TM) BGC DEVICE | ODC | Substantially Equivalent | Smart Medical Systems , Ltd. | accessdata.fda.gov |
Compare with other makers
Updated April 11, 2022. 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.