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

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..

Clearance details

Applicant: Edan Instruments, Inc.
Product code: Code IYO
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 ↗

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.