6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) (K241671)
Description
6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) by Esaote, S.P.A., an FDA 510(k) cleared radiology device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241671
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. 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) (K241671) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K230179 | 6440 MyLabX90 | Esaote, S.p.A. | 2023 |
| K192157 | 6450 Ultrasound system | Esaote, S.p.A. | 2019 |
Trace the full predicate network for K241671
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.