Cleared Traditional

Deepsight NeedleVue LC1 Ultrasound System

K250381 · DeepSight Technology, Inc. · Radiology

Aug 2025

Decision

171d

Days

Class 2

Risk

About This 510(k) Submission

K250381 is an FDA 510(k) clearance for the Deepsight NeedleVue LC1 Ultrasound System, a System, Imaging, Pulsed Echo, Ultrasonic (Class II — Special Controls, product code IYO), submitted by DeepSight Technology, Inc. (Santa Clara, US). The FDA issued a Cleared decision on August 1, 2025, 171 days after receiving the submission on February 11, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1560.

Submission Details

510(k) Number	K250381 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 11, 2025
Decision Date	August 01, 2025
Days to Decision	171 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF