Class Class II
Rapid CTA 360 (K251151)
Description
Rapid CTA 360 by Ischemaview, an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK251151
Clearance Date2025-07-16
Clearance TypeTraditional
Product CodeQAS
Regulation Number892.2080
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251151
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 CTA 360 (K251151) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K243350 | Rapid Neuro3D | Ischemaview, Inc. | 2025 |
| K200941 | Rapid LVO | Ischemaview, Inc. | 2020 |
Trace the full predicate network for K251151
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.