Class Class II
OEC One ASD (K240828)
Description
OEC One ASD by Ge Hualun Medical Systems Co. , Ltd., an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK240828
Clearance Date2024-12-27
Clearance TypeTraditional
Product CodeOXO
Regulation Number892.1650
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K240828
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. OEC One ASD (K240828) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K182626 | OEC One | Ge Hualun Medical Systems Co. , Ltd. | 2018 |
Trace the full predicate network for K240828
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.