Data / Medical devices / Israel / Nano-X Imaging Ltd
Nano-X Imaging Ltd: FDA-registered device maker in PETAH TIKVA Central, Israel, 4 510(k) clearances
Nano-X Imaging Ltd is registered with the FDA (registration 3027605321) in PETAH TIKVA Central, Israel. It lists 3 device types. The FDA files 4 510(k) clearances under its listings, the newest dated February 2, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3027605321
- Address
- 94 Em Hamoshavot Road Brosh building Ofer Tech Park PO Box 3486, PETAH TIKVA Central, Israel, 4910402
- Owner or operator
- Nano-X Imaging Ltd (10088182)
- Roles
- Manufacturer
- First device listed
- June 7, 2023
- Registered through
- 2027
- Brand names listed
- Nanox.ARC, Nanox.ARC X, TAP2D
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | MQB | 2 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | accessdata.fda.gov |
| System, X-Ray, Tomographic | IZF | 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 |
|---|---|---|---|---|---|---|
| February 2, 2026 | K252649 | TAP2D | IZF | Substantially Equivalent | Nano-X Imaging , Ltd. | accessdata.fda.gov |
| April 16, 2025 | K250850 | Nanox.ARC X | IZF | Substantially Equivalent | Nano-X Imaging , Ltd. | accessdata.fda.gov |
| December 4, 2024 | K242395 | Nanox.ARC | IZF | Substantially Equivalent | Nano-X Imaging , Ltd. | accessdata.fda.gov |
| April 28, 2023 | K222934 | Nanox.ARC | IZF | Substantially Equivalent | Nano-X Imaging , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Solid State X-Ray Imager (Flat Panel/Digital Imager)
- All makers of System, X-Ray, Tomographic
- All makers of System, Image Processing, Radiological
Updated February 2, 2026. 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.