EchoPAC Software Only / EchoPAC Plug-in (K251342)
Description
EchoPAC Software Only / EchoPAC Plug-in by GE Medical Systems Ultrasound and Primary Care Diagnostics, an FDA 510(k) cleared radiology device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251342
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. EchoPAC Software Only / EchoPAC Plug-in (K251342) cites 7 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K243226 | Ultrasound Imaging System (LU700 Series); Ultrasound Imagin... | Leltek, Inc. | 2025 |
| K243620 | Vivid iq | GE Medical Systems Ultrasound and P... | 2025 |
| K231965 | Voluson Expert 22, Voluson Expert 20, Voluson Expert 18 | GE Medical Systems Ultrasound and P... | 2023 |
| K220940 | EchoPAC Software Only, EchoPAC Plug-in | GE Medical Systems Ultrasound and P... | 2022 |
| K200852 | EchoPAC Software Only, EchoPAC Plug-In | GE Medical Systems Ultrasound and P... | 2020 |
| K181685 | Vivid E80, Vivid E90, Vivid E95 | GE Medical Systems Ultrasound and P... | 2018 |
| K170847 | EchoPAC Software Only, EchoPAC Plug-in | GE Medical Systems Ultrasound and P... | 2017 |
Trace the full predicate network for K251342
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.