Data / Medical devices / Israel / Arineta Ltd.
Arineta Ltd.: FDA-registered device maker in Caesarea Industrial Zone Northern, Israel, 5 510(k) clearances
Arineta Ltd. is registered with the FDA (registration 3010642685) in Caesarea Industrial Zone Northern, Israel. It lists 1 device type. The FDA files 5 510(k) clearances under its listings, the newest dated April 15, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010642685
- Address
- 15 Halamish Street, Caesarea Industrial Zone Northern, Israel, 3088900
- Owner or operator
- Arineta, Ltd. (10052807)
- Roles
- Manufacturer
- First device listed
- October 7, 2016
- Registered through
- 2026
- Brand names listed
- CardioGraphe, CardioGraphe with Lateral Table, SpotLight, SpotLight CT, SpotLight CT with Lateral Table, SpotLight Duo, SpotLight Duo, SpotLight CT, CardioGraphe, SpotLight/SpotLight Duo (with DLIR option) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, X-Ray, Tomography, Computed | JAK | 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 15, 2025 | K250650 | SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option | JAK | Substantially Equivalent | Arineta , Ltd. | accessdata.fda.gov |
| January 13, 2025 | K241200 | SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening Option | JAK | Substantially Equivalent | Arineta , Ltd. | accessdata.fda.gov |
| October 13, 2023 | K230370 | SpotLight/SpotLight Duo (with DLIR option) | JAK | Substantially Equivalent | Arineta , Ltd. | accessdata.fda.gov |
| December 2, 2022 | K213465 | CardioGraphe | JAK | Substantially Equivalent | Arineta , Ltd. | accessdata.fda.gov |
| August 10, 2016 | K161066 | SpotLight CT | JAK | Substantially Equivalent | Arineta , Ltd. | accessdata.fda.gov |
Compare with other makers
Updated April 15, 2025. 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.