Class Class II
Revolution Vibe (K250941)
Description
Revolution Vibe by Ge Medical Systems, LLC, an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250941
Clearance Date2025-08-01
Clearance TypeTraditional
Product CodeJAK
Regulation Number892.1750
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250941
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. Revolution Vibe (K250941) cites 4 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K213999 | Deep Learning Image Reconstruction | Ge Medical Systems, LLC | 2022 |
| K213715 | Revolution Apex, Revolution Apex Elite, Revolution Apex Plu... | Ge Medical Systems, LLC | 2021 |
| K201745 | Deep Learning Image Reconstruction for Gemstone Spectral Im... | Ge Medical Systems, LLC | 2020 |
| K183202 | Deep Learning Image Reconstruction | Ge Medical Systems, LLC | 2019 |
Trace the full predicate network for K250941
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.