Class Class II
P-Cure Proton Therapy System (PPTS) (K242418)
Description
P-Cure Proton Therapy System (PPTS) by P-Cure, Ltd., an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242418
Clearance Date2025-05-12
Clearance TypeTraditional
Product CodeLHN
Regulation Number892.5050
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242418
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. P-Cure Proton Therapy System (PPTS) (K242418) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K221996 | P-Cure Proton Beam Therapy System | P-Cure, Ltd. | 2023 |
| K191521 | Radiance 330 Proton Beam Therapy System | Protom International Holding Corpor... | 2019 |
Trace the full predicate network for K242418
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.