X9 Ultrasound System— 510(k) K251673

Substantially Equivalent

X9, Inc.

FDA 510(k) clearance K251673 for X9 Ultrasound System, Substantially Equivalent on 2025-10-17. Applicant: X9, Inc..

Clearance details

Applicant: X9, Inc.
Product code: Code SGH
Advisory panel: Radiology
Date received: 2025-05-30
Decision date: 2025-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wallingford, CT, US

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