Class Class II
iCAC Device (K230223)
Description
iCAC Device by Bunkerhill, Inc., an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK230223
Clearance Date2023-04-25
Clearance TypeTraditional
Product CodeJAK
Regulation Number892.1750
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K230223
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. iCAC Device (K230223) cites 1 predicate device and is itself cited by 4 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K210085 | HealthCCSng | Zebra Medical Vision, Ltd. | 2021 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K260166 | Bunkerhill Contrast CAC | BunkerHill Health | 2026 |
| K243229 | Bunkerhill AVC | BunkerHill Health | 2025 |
| K242188 | ClearRead CT CAC | Riverain Technologies, Inc. | 2024 |
| K231631 | BriefCase-Quantification | Aidoc Medical , Ltd. | 2023 |
Trace the full predicate network for K230223
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.