Class Class II
Rapid NCCT Stroke (K222884)
Description
Rapid NCCT Stroke by Ischemaview, Inc., an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK222884
Clearance Date2023-03-02
Clearance TypeTraditional
Product CodeQAS
Regulation Number892.2080
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K222884
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. Rapid NCCT Stroke (K222884) cites 1 predicate device and is itself cited by 3 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K200855 | CINA | Avicenna.Ai | 2020 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K253818 | Annalise Enterprise | Harrison-AI Medical Pty, Ltd. | 2026 |
| K250685 | Methinks NCCT Stroke | Methinks Software, S.L | 2025 |
| K232496 | Brainomix 360 Triage Stroke | Brainomix Limited | 2023 |
Trace the full predicate network for K222884
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.