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Nanox.ARC
NANO-X IMAGING LTD · Model 2.2. · UDI-DI 07290018465004
10
510(k) clearances
44
Adverse events (1 deaths)
6
Recalls
21
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-18 | AGFA Healthcare Corp. | It is possible to exceed the maximum allowed Air Kerma rate (AKR) of 88mGy/min for pulsed fluoro exams. This can happen in case the framerate is increased on the NX workstation whe |
| 2020-02-10 | Agfa N.V. | Tomosynthesis image acquisition sequence did not stop automatically after expected number of exposures. |
| 2018-07-16 | Philips Electronics North America Corporation | There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. |
| 2018-07-16 | Philips Electronics North America Corporation | There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. |
| 2018-07-16 | Philips Electronics North America Corporation | There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. |
| 2003-04-15 | Siemens Medical Solutions USA, Inc | the back up safety catch may not function properly |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.