Class Class II
Nanox.ARC (K222934)
Description
Nanox.ARC by Nano-X Imaging , Ltd., an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK222934
Clearance Date2023-04-28
Clearance TypeTraditional
Product CodeIZF
Regulation Number892.1740
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K222934
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Nanox.ARC (K222934) cites 2 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K193262 | DR 600 with Tomosynthesis | Agfa N.V. | 2020 |
| K183275 | DR 800 with Tomosynthesis | Agfa N.V. | 2019 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K242395 | Nanox.ARC | Nano-X Imaging , Ltd. | 2024 |
Trace the full predicate network for K222934
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.