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FDA 510(k)

Deepsight NeedleVue LC1 Ultrasound System

K-Number: K250381 · 2025-08-01

ApplicantDeepSight Technology, Inc.
Decision Date2025-08-01
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Deepsight NeedleVue LC1 Ultrasound System is a medical device manufactured by DeepSight Technology, Inc.. It received FDA 510(k) clearance on 2025-08-01 under approval number K250381. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Deepsight NeedleVue LC1 Ultrasound System?

Deepsight NeedleVue LC1 Ultrasound System is a medical device that received FDA 510(k) clearance on 2025-08-01. It is manufactured by DeepSight Technology, Inc.. The 510(k) number is K250381.

When was Deepsight NeedleVue LC1 Ultrasound System approved by the FDA?

Deepsight NeedleVue LC1 Ultrasound System received FDA 510(k) clearance on 2025-08-01, under approval number K250381.

What company makes Deepsight NeedleVue LC1 Ultrasound System?

Deepsight NeedleVue LC1 Ultrasound System is manufactured by DeepSight Technology, Inc..

What is the FDA product code for Deepsight NeedleVue LC1 Ultrasound System?

The FDA product code for Deepsight NeedleVue LC1 Ultrasound System is IYO.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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