Sonosite LX and Sonosite PX Ultrasound Systems
K-Number: K251106 · 2025-08-29
ApplicantFUJIFILM Sonosite, Inc.
Decision Date2025-08-29
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Sonosite LX and Sonosite PX Ultrasound Systems is a medical device manufactured by FUJIFILM Sonosite, Inc.. It received FDA 510(k) clearance on 2025-08-29 under approval number K251106. 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 and Sonosite PX Ultrasound Systems?
Sonosite LX and Sonosite PX Ultrasound Systems is a medical device that received FDA 510(k) clearance on 2025-08-29. It is manufactured by FUJIFILM Sonosite, Inc.. The 510(k) number is K251106.
When was Sonosite LX and Sonosite PX Ultrasound Systems approved by the FDA?
Sonosite LX and Sonosite PX Ultrasound Systems received FDA 510(k) clearance on 2025-08-29, under approval number K251106.
What company makes Sonosite LX and Sonosite PX Ultrasound Systems?
Sonosite LX and Sonosite PX Ultrasound Systems is manufactured by FUJIFILM Sonosite, Inc..
What is the FDA product code for Sonosite LX and Sonosite PX Ultrasound Systems?
The FDA product code for Sonosite LX and Sonosite PX Ultrasound Systems is IYN.
Related Clinical Trials
Other Devices by FUJIFILM Sonosite, Inc.
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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.