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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is X9, Inc.. It received FDA 510(k) clearance on 2025-10-17 under 510(k) 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. The listed applicant is X9, Inc.. The 510(k) number is K251673.

When did X9 Ultrasound System receive FDA 510(k) clearance?

X9 Ultrasound System received FDA 510(k) clearance on 2025-10-17, under 510(k) number K251673.

Who is the listed applicant for X9 Ultrasound System?

The FDA 510(k) record lists X9, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for X9 Ultrasound System?

The FDA product code for X9 Ultrasound System is SGH.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07548151Guided Needle Insertion for Vascular AccessCOMPLETED

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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