Class Class II
Vivid T9/Vivid T8 (K243628)
Description
Vivid T9/Vivid T8 by GE Medical Systems Ultrasound and Primary Care Diagnostics, an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243628
Clearance Date2025-02-11
Clearance TypeTraditional
Product CodeIYN
Regulation Number892.1550
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243628
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 T9/Vivid T8 (K243628) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K221147 | Vivid T8, Vivid T9 | GE Medical Systems Ultrasound and P... | 2022 |
| K220619 | Vivid S60N, Vivid S70N | GE Medical Systems Ultrasound and P... | 2022 |
| K211524 | LOGIQ E10s, LOGIQ Fortis | GE Healthcare | 2021 |
Trace the full predicate network for K243628
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.