Versana Premier; Versana Premier Lotus; LOGIQ F (K242005)
Description
Versana Premier; Versana Premier Lotus; LOGIQ F 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 K242005
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. Versana Premier; Versana Premier Lotus; LOGIQ F (K242005) cites 7 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K231989 | LOGIQ E10s, LOGIQ Fortis | Ge Medical Systems Ultrasound and P... | 2023 |
| K221147 | Vivid T8, Vivid T9 | GE Medical Systems Ultrasound and P... | 2022 |
| K220800 | Venue Go | GE Medical Systems Ultrasound and P... | 2022 |
| K220446 | Versana Balance | GE Medical Systems Ultrasound and P... | 2022 |
| K214039 | LOGIQ P10, LOGIQ P9, LOGIQ P8 | GE Medical Systems Ultrasound and P... | 2022 |
| K213642 | Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S... | GE Healthcare | 2022 |
| K210438 | Versana Premier | GE Medical Systems Ultrasound and P... | 2021 |
Trace the full predicate network for K242005
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.