Class Class II
Definium Pace Select ET (K242678)
Description
Definium Pace Select ET by Ge Hualun Medical Systems Co. , Ltd., an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242678
Clearance Date2024-10-01
Clearance TypeSpecial
Product CodeKPR
Regulation Number892.1680
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242678
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. Definium Pace Select ET (K242678) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K231892 | Definium Pace Select | Ge Hualun Medical Systems Co. , Ltd. | 2023 |
| K191699 | Discovery XR656 HD with VolumeRad | Ge Hualun Medical Systems Co. , Ltd. | 2019 |
Trace the full predicate network for K242678
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.