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FDA 510(k)

Sonosite LX Ultrasound System

K-Number: K233597 · 2023-12-06

Decision Date2023-12-06
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Sonosite LX Ultrasound System is a medical device manufactured by FUJIFILM Sonosite, Inc.. It received FDA 510(k) clearance on 2023-12-06 under approval number K233597. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sonosite LX Ultrasound System?

Sonosite LX Ultrasound System is a medical device that received FDA 510(k) clearance on 2023-12-06. It is manufactured by FUJIFILM Sonosite, Inc.. The 510(k) number is K233597.

When was Sonosite LX Ultrasound System approved by the FDA?

Sonosite LX Ultrasound System received FDA 510(k) clearance on 2023-12-06, under approval number K233597.

What company makes Sonosite LX Ultrasound System?

Sonosite LX Ultrasound System is manufactured by FUJIFILM Sonosite, Inc..

What is the FDA product code for Sonosite LX Ultrasound System?

The FDA product code for Sonosite LX Ultrasound System is IYN.

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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.