Class Class II
Cardiac Guidance (K243065)
Description
Cardiac Guidance by Caption Health, Inc., an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243065
Clearance Date2025-01-15
Clearance TypeTraditional
Product CodeQJU
Regulation Number892.2100
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243065
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. Cardiac Guidance (K243065) cites 0 predicate devices and is itself cited by 1 later device.
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K251322 | Venue; Venue Go; Venue Fit; Venue Sprint | GE Medical Systems Ultrasound and P... | 2025 |
Trace the full predicate network for K243065
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.