UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program (K250328)
Description
UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program by Canon Medical Systems Corporation, an FDA 510(k) cleared radiology device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250328
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. UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program (K250328) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K223017 | Aplio i900/i800/i700 Diagnostic Ultrasound System, Software... | Canon Medical Systems Corporation | 2023 |
| K121076 | ULTRAEXTEND FX, ULTRASOUND WORKSTATION PACKAGE | Toshiba America Medical Systems, In.C | 2012 |
Trace the full predicate network for K250328
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.