Class Class II
Portable X-ray System (K223010)
Description
Portable X-ray System by Iray Technology Taicang , Ltd., an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223010
Clearance Date2023-01-17
Clearance TypeTraditional
Product CodeEHD
Regulation Number872.1800
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223010
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. Portable X-ray System (K223010) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K172810 | PORT-X IV | Genoray Co., Ltd. | 2018 |
| K081664 | NOMAD PRO X-RAY SYSTEM | Aribex, Inc. | 2008 |
Trace the full predicate network for K223010
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.