Class Class II
Vivid iq (K243620)
Description
Vivid iq by GE Medical Systems Ultrasound and Primary Care Diagnostics, an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243620
Clearance Date2025-02-11
Clearance TypeTraditional
Product CodeIYN
Regulation Number892.1550
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243620
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. Vivid iq (K243620) cites 6 predicate devices and is itself cited by 2 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K240050 | SOUNDSTAR™ CRYSTAL Ultrasound Catheter | Biosense Webster, Inc. | 2024 |
| K232186 | LOGIQ e | Ge Medical Systems Ultrasound and P... | 2023 |
| K233270 | AcuNav Crystal Ultrasound Catheter | Siemens Medical Solutions USA, Inc. | 2023 |
| K221148 | Vivid iq | GE Medical Systems Ultrasound & Pri... | 2022 |
| K220619 | Vivid S60N, Vivid S70N | GE Medical Systems Ultrasound and P... | 2022 |
| K211524 | LOGIQ E10s, LOGIQ Fortis | GE Healthcare | 2021 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K251342 | EchoPAC Software Only / EchoPAC Plug-in | GE Medical Systems Ultrasound and P... | 2025 |
| K251169 | Vivid Pioneer | GE Medical Systems Ultrasound and P... | 2025 |
Trace the full predicate network for K243620
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.