Sonosite MT Ultrasound System
K-Number: K253448 · 2025-11-03
ApplicantFUJIFILM Sonosite, Inc.
Decision Date2025-11-03
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Sonosite MT Ultrasound System is a medical device manufactured by FUJIFILM Sonosite, Inc.. It received FDA 510(k) clearance on 2025-11-03 under approval number K253448. 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 MT Ultrasound System?
Sonosite MT Ultrasound System is a medical device that received FDA 510(k) clearance on 2025-11-03. It is manufactured by FUJIFILM Sonosite, Inc.. The 510(k) number is K253448.
When was Sonosite MT Ultrasound System approved by the FDA?
Sonosite MT Ultrasound System received FDA 510(k) clearance on 2025-11-03, under approval number K253448.
What company makes Sonosite MT Ultrasound System?
Sonosite MT Ultrasound System is manufactured by FUJIFILM Sonosite, Inc..
What is the FDA product code for Sonosite MT Ultrasound System?
The FDA product code for Sonosite MT 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.