K250214

Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix AX8, Acclarix AX75, Acclarix AX78, Acclarix AX8 Exp, Acclarix AX8 Super), Acclarix AX9 Series Diagnostic Ultrasound Szystem (Model: Acclarix AX9 Basic, Acclarix AX9, Acclarix AX9 Exp, Acclarix AX9 Super, Acclarix AX85, Acclarix AX88)

510(k) number: K250214
Device name: Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix AX8, Acclarix AX75, Acclarix AX78, Acclarix AX8 Exp, Acclarix AX8 Super), Acclarix AX9 Series Diagnostic Ultrasound Szystem (Model: Acclarix AX9 Basic, Acclarix AX9, Acclarix AX9 Exp, Acclarix AX9 Super, Acclarix AX85, Acclarix AX88)
Applicant: Edan Instruments, Inc. CN
Product code: IYN — System, Imaging, Pulsed Doppler, Ultrasonic
Decision date: 2025-02-20
Date received: 2025-01-24
Decision: Substantially Equivalent
Clearance type: Traditional
Flag: Third-party review
Advisory committee: Radiology

PDFDownload 510(k) SummaryArchived here · 1.8 MB · U.S. public domain

Also available from FDA: K250214.pdf

Official FDA record: K250214

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.