Class Class II
CardIQ Suite (K243672)
Description
CardIQ Suite by GE Medical Systems SCS, an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243672
Clearance Date2025-06-18
Clearance TypeTraditional
Product CodeJAK
Regulation Number892.1750
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243672
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. CardIQ Suite (K243672) cites 2 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K233731 | CardIQ Suite | GE Medical Systems SCS | 2024 |
| K020929 | SMARTSCORE 3.5; SMARTSCORE 4.0; SMARTSCORE 4.5 | GE Medical Systems | 2002 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K253770 | CardIQ Suite | GE Medical Systems SCS | 2026 |
Trace the full predicate network for K243672
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.