Nanox Cart X-ray System
FDA 510(k) K203782 · Nano-X Imaging , Ltd.
510(k) numberK203782
Submission
- Device name
- Nanox Cart X-ray System
- Applicant
- Nano-X Imaging , Ltd.
Neve Ilan, IL - Received
- December 28, 2020
- Decision date
- April 1, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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Questions and answers
When was Nanox Cart X-ray System cleared by the FDA?
Nanox Cart X-ray System (K203782) received a 510(k) decision of Substantially Equivalent on April 1, 2021, 94 days after the submission was received.
What is the product code of K203782?
The FDA product code is IZL – System, X-Ray, Mobile, a Class II (moderate risk) device regulated under 21 CFR 892.1720.