Nano-X Imaging, Ltd.
IsraelFDA 510(k) applicant, unverified FDA
- Devices
- 8
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Nano-X Imaging, Ltd. makes
Nano-X Imaging, Ltd. manufactures multi-directional tomography x-ray systems, including the Nanox.ARC, Nanox.ARC X, Nanox Cart X-ray System, and TAP2D.
The company's devices are classified as Class II and are listed in the FDA 510(k) and FDA UDI registries. Nano-X Imaging is based in the US.
Catalogue
- GUDID
- GUDID
- GUDID
Nanox Cart X-ray System Ref K203782
510(k) 510(k)TAP2D Ref K252649
510(k) 510(k)Nanox.ARC Ref K222934
510(k) 510(k)Nanox.ARC Ref K242395
510(k) 510(k)Nanox.ARC X Ref K250850
510(k) 510(k)
Company details
- DUNS number
- 521092973
FDA establishments
- Nano-X Imaging Ltd PETAH TIKVA Central · IL FEI 3027605321
Frequently asked questions
How many devices does Nano-X Imaging, Ltd. have in the registry?
The registry currently lists 8 devices for Nano-X Imaging, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Nano-X Imaging, Ltd.'s devices?
Among its 8 most recently registered devices, Nano-X Imaging, Ltd. has devices listed in FDA 510(k) (5 devices) and FDA GUDID (3 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Nano-X Imaging, Ltd.'s devices fall under?
Among its 8 most recently registered devices, the classes recorded for Nano-X Imaging, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Nano-X Imaging, Ltd. in the registry?
The most recently registered devices listed for Nano-X Imaging, Ltd. include TAP2D 1.0, Nanox.ARC 2.2., Nanox.ARC X and Nanox Cart X-ray System.
Which FDA establishments are linked to Nano-X Imaging, Ltd.?
1 FDA establishment is linked to Nano-X Imaging, Ltd. in the registry; they are listed on the company page.