Class Class II
Deepsight NeedleVue LC1 Ultrasound System (K250381)
Description
Deepsight NeedleVue LC1 Ultrasound System by DeepSight Technology, Inc., an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250381
Clearance Date2025-08-01
Clearance TypeTraditional
Product CodeIYO
Regulation Number892.1560
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250381
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. Deepsight NeedleVue LC1 Ultrasound System (K250381) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K152309 | LOGIQ E9, LOGIQ E9 XDClear 2.0 | GE Medical Systems Ultrasound and P... | 2015 |
Trace the full predicate network for K250381
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.