iLab Ultrasound Imaging System— 510(k) K152316

Substantially Equivalent

Boston Scientific

FDA 510(k) clearance K152316 for iLab Ultrasound Imaging System, Substantially Equivalent on 2015-09-18. Applicant: Boston Scientific.

Clearance details

Applicant: Boston Scientific
Product code: Code IYO
Advisory panel: Radiology
Date received: 2015-08-17
Decision date: 2015-09-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Fremont, 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.