Data / Medical devices / Israel / Nano-X AI Ltd.
Nano-X AI Ltd.: FDA-registered device maker in Petah Tikva Central, Israel, 7 510(k) clearances
Nano-X AI Ltd. is registered with the FDA (registration 3012453401) in Petah Tikva Central, Israel. It lists 4 device types. The FDA files 7 510(k) clearances under its listings, the newest dated August 19, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012453401
- Address
- Shlomo Shmeltzer Road 94 PO BOX 3486 ISRAEL, Petah Tikva Central, Israel, 4970602
- Owner or operator
- Nano-X AI Ltd. (10050295)
- Roles
- Manufacturer
- First device listed
- May 7, 2019
- Registered through
- 2026
- Brand names listed
- HealthCCSng, HealthCCSng V2, HealthFLD, HealthICH, HealthOST, HealthPNX, HealthPPT, Nanox AI Web Viewer
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Radiological Computer-Assisted Prioritization Software For Lesions | QFM | 2 | Manufacturer | accessdata.fda.gov |
| Radiological Computer-Assisted Triage And Notification Software | QAS | 2 | Manufacturer | accessdata.fda.gov |
| System, Digital Image Communications, Radiological | LMD | 1 | Manufacturer | accessdata.fda.gov |
| 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 |
|---|---|---|---|---|---|---|
| August 19, 2024 | K241440 | HealthCCSng | JAK | Substantially Equivalent | Nano-X AI , Ltd. | accessdata.fda.gov |
| February 8, 2024 | K233080 | HealthFLD | JAK | Substantially Equivalent | Nano-X AI , Ltd. | accessdata.fda.gov |
| April 22, 2022 | K213944 | HealthOST | JAK | Substantially Equivalent | Nanoxai , Ltd. | accessdata.fda.gov |
| December 15, 2021 | K211803 | HealthPPT | QFM | Substantially Equivalent | Zebra Medical Vision, Ltd. | accessdata.fda.gov |
| September 15, 2021 | K210085 | HealthCCSng | JAK | Substantially Equivalent | Zebra Medical Vision, Ltd. | accessdata.fda.gov |
| June 13, 2019 | K190424 | HealthICH | QAS | Substantially Equivalent | Zebra Medical Vision, Ltd. | accessdata.fda.gov |
| May 6, 2019 | K190362 | HealthPNX | QFM | Substantially Equivalent | Zebra Medical Vision, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of System, X-Ray, Tomography, Computed
- All makers of System, Digital Image Communications, Radiological
- All makers of Radiological Computer-Assisted Triage And Notification Software
- All makers of Radiological Computer-Assisted Prioritization Software For Lesions
Updated August 19, 2024. 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.