X9 Ultrasound System
K-Number: K251673 · 2025-10-17
ApplicantX9, Inc.
Decision Date2025-10-17
Product CodeSGH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
X9 Ultrasound System is a medical device manufactured by X9, Inc.. It received FDA 510(k) clearance on 2025-10-17 under approval number K251673. The device is classified under product code SGH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the X9 Ultrasound System?
X9 Ultrasound System is a medical device that received FDA 510(k) clearance on 2025-10-17. It is manufactured by X9, Inc.. The 510(k) number is K251673.
When was X9 Ultrasound System approved by the FDA?
X9 Ultrasound System received FDA 510(k) clearance on 2025-10-17, under approval number K251673.
What company makes X9 Ultrasound System?
X9 Ultrasound System is manufactured by X9, Inc..
What is the FDA product code for X9 Ultrasound System?
The FDA product code for X9 Ultrasound System is SGH.
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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.