# K250381: Deepsight NeedleVue LC1 Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: DeepSight Technology, Inc.
- Decided: Aug 1, 2025 after 171 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 18 generations back to K935595 (1995). 150 ancestors in all.
No later device cites it as a predicate yet.
0 of 151 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152309: LOGIQ E9, LOGIQ E9 XDClear 2.0, GE Medical Systems Ultrasound and Primary Care Diagnostics (2015) Summary page 5.

## Indications for use
The DeepSight NeedleVue LC1 Ultrasound System is intended for use in Abdominal, Pediatric, Small Organ, Peripheral Vascular, Fetal, Urological, and Musculoskeletal Conventional and Superficial Imaging. This device is indicated for Prescription Use Only and by qualified healthcare professionals (HCPs). The DeepSight NeedleVue LC1 ultrasound system is intended to be used by qualified and trained physicians or sonographers with at least basic ultrasound knowledge. The operator must have read and understood the user manual. The DeepSight NeedleVue LC1 ultrasound system is intended to be used in medical practices and clinical environments including healthcare facilities, hospitals and clinics.

Source page: https://510kreport.com/device/K250381
Methodology: https://510kreport.com/methodology