Class Class II
Vscan Air (K250087)
Description
Vscan Air by GE Medical Systems Ultrasound and Primary Care Diagnostics, an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250087
Clearance Date2025-05-01
Clearance TypeTraditional
Product CodeIYN
Regulation Number892.1550
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250087
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. Vscan Air (K250087) cites 1 predicate device and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K231301 | Vscan Air | GE Medical Systems Ultrasound and P... | 2023 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K260595 | Sonosite iLOOK Ultrasound System | FUJIFILM Sonosite, Inc. | 2026 |
Trace the full predicate network for K250087
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.