Class Class II
Vivid Pioneer (K251169)
Description
Vivid Pioneer by GE Medical Systems Ultrasound and Primary Care Diagnostics, an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK251169
Clearance Date2025-07-10
Clearance TypeTraditional
Product CodeIYN
Regulation Number892.1550
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251169
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 Pioneer (K251169) cites 8 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K243620 | Vivid iq | GE Medical Systems Ultrasound and P... | 2025 |
| K231989 | LOGIQ E10s, LOGIQ Fortis | Ge Medical Systems Ultrasound and P... | 2023 |
| K231965 | Voluson Expert 22, Voluson Expert 20, Voluson Expert 18 | GE Medical Systems Ultrasound and P... | 2023 |
| K223832 | Vivid S60N, Vivid S70N | Ge Medical System Ultrasound and Pr... | 2023 |
| K220882 | Vivid E80, Vivid E90, Vivid E95 | Ge Medical Systems Ultrasound And | 2022 |
| K200743 | Vivid E80/ Vivid E90/ Vivid E95 | Ge Medical Systems Ultrasound And | 2020 |
| K181685 | Vivid E80, Vivid E90, Vivid E95 | GE Medical Systems Ultrasound and P... | 2018 |
| K170823 | Vivid E80, Vivid E90, Vivid E95 | GE Medical Systems Ultrasound and P... | 2017 |
Trace the full predicate network for K251169
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.