Class Class II
Mendaera Guidance System (K250524)
Description
Mendaera Guidance System by Mendaera, Inc., an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250524
Clearance Date2025-07-02
Clearance TypeTraditional
Product CodeITX
Regulation Number892.1570
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250524
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. Mendaera Guidance System (K250524) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K160806 | Verza Guidance System | CIVCO Medical Instruments Co., Inc. | 2016 |
| K093713 | ULTRASOUND GENERAL PURPOSE GUIDANCE SYSTEM | Civco Medical Instruments | 2010 |
Trace the full predicate network for K250524
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.