Class Class II
FEops HEARTguideTM, FEops HEARTguideTM ALPACA (K223855)
Description
FEops HEARTguideTM, FEops HEARTguideTM ALPACA by Feops NV, an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223855
Clearance Date2023-06-06
Clearance TypeTraditional
Product CodeQIH
Regulation Number892.2050
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223855
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. FEops HEARTguideTM, FEops HEARTguideTM ALPACA (K223855) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K153736 | 3mensio Workstation | Pie Medical Imaging BV | 2016 |
Trace the full predicate network for K223855
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.