ATUSA Automated 3D Breast Ultrasound System— 510(k) K213620

Substantially Equivalent

Isono Health, Inc.

FDA 510(k) clearance K213620 for ATUSA Automated 3D Breast Ultrasound System, Substantially Equivalent on 2022-04-22. Applicant: Isono Health, Inc..

Clearance details

Applicant: Isono Health, Inc.
Product code: Code IYO
Advisory panel: Radiology
Date received: 2021-11-16
Decision date: 2022-04-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South San Francisco, CA, US

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.