Class Class II
Bunkerhill Abdominal Aortic Quantification (AAQ) (K243779)
Description
Bunkerhill Abdominal Aortic Quantification (AAQ) by BunkerHill Health, an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243779
Clearance Date2025-07-01
Clearance TypeTraditional
Product CodeQIH
Regulation Number892.2050
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243779
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. Bunkerhill Abdominal Aortic Quantification (AAQ) (K243779) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K230534 | BriefCase-Quantification | Aidoc Medical , Ltd. | 2023 |
Trace the full predicate network for K243779
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.