Data / Medical devices / Israel / Radiaction Ltd.
Radiaction Ltd.: FDA-registered device maker in Tel Aviv, Israel, 2 510(k) clearances
Radiaction Ltd. is registered with the FDA (registration 3022378058) in Tel Aviv, Israel. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated September 30, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3022378058
- Address
- 10 HaNechoshet St., Tel Aviv, Israel, 6971072
- Owner or operator
- Radiaction Ltd. (10084821)
- Roles
- Manufacturer
- First device listed
- April 11, 2022
- Registered through
- 2026
- Brand names listed
- Shield System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Interventional Fluoroscopic X-Ray System | OWB | 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 |
|---|---|---|---|---|---|---|
| September 30, 2022 | K222625 | Shield System | OWB | Substantially Equivalent | Radiaction , Ltd. | accessdata.fda.gov |
| March 30, 2022 | K212159 | Shield System | OWB | Substantially Equivalent | Radiaction , Ltd. | accessdata.fda.gov |
Compare with other makers
Updated September 30, 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.