Class Class II
Monaco RTP System (K223233)
Description
Monaco RTP System by Elekta Solutions AB, an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223233
Clearance Date2023-02-23
Clearance TypeTraditional
Product CodeMUJ
Regulation Number892.5050
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223233
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. Monaco RTP System (K223233) cites 1 predicate device and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K213787 | Monaco RTP System | Elekta Solutions AB | 2022 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K252002 | Monaco RTP System (6.3) | Elekta Solutions AB | 2026 |
Trace the full predicate network for K223233
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.