Voluson™ Performance 16; Voluson™ Performance 18 (K250543)
Description
Voluson™ Performance 16; Voluson™ Performance 18 by GE Medical Systems Ultrasound and Primary Care Diagnostics, an FDA 510(k) cleared radiology device.
Regulatory Information
FDA Database
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Predicate lineage for K250543
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. Voluson™ Performance 16; Voluson™ Performance 18 (K250543) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K242168 | Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 | GE Medical Systems Ultrasound and P... | 2024 |
| K233692 | Voluson Signature 20, Voluson Signature 18 | GE Medical Systems Ultrasound and P... | 2024 |
| K230346 | Voluson SWIFT; Voluson SWIFT+ | Ge Medical Systems Ultrasound & Pri... | 2023 |
Trace the full predicate network for K250543
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.