Axialis Ophthalmic Ultrasound System— 510(k) K213254

Substantially Equivalent

Quantel Medical

FDA 510(k) clearance K213254 for Axialis Ophthalmic Ultrasound System, Substantially Equivalent on 2021-11-15. Applicant: Quantel Medical.

Clearance details

Applicant: Quantel Medical
Product code: Code IYO
Advisory panel: Radiology
Date received: 2021-09-30
Decision date: 2021-11-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cournon D' Auvergne-Cedex, FR

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.