Acclarix AX8 Diagnostic Ultrasound System, Acclarix LX8 Diagnostic Ultrasound System— 510(k) K171824

Name: FDA 510(k) clearance K171824
Creator: U.S. Food and Drug Administration
Published: 2017-07-18

Substantially Equivalent

Edan Instruments, Inc.

FDA 510(k) clearance K171824 for Acclarix AX8 Diagnostic Ultrasound System, Acclarix LX8 Diagnostic Ultrasound System, Substantially Equivalent on 2017-07-18. Applicant: Edan Instruments, Inc.. Device class: 2.

Clearance details

Applicant: Edan Instruments, Inc.
Product code: Code IYO
Device class: Class 2
Regulation: 21 CFR 892.1560
Advisory panel: Radiology
Date received: 2017-06-19
Decision date: 2017-07-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

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Adverse events under product code IYO

product code IYO

Malfunction: 3,339
Total: 3,339

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.