I REVIEW SOFTWARE(ACCESSORY TO) ILAB ULTRASOUND IMAGING SYSTEM) VERSION1.0— 510(k) K063493

Substantially Equivalent

Boston Scientific Corp

FDA 510(k) clearance K063493 for I REVIEW SOFTWARE(ACCESSORY TO) ILAB ULTRASOUND IMAGING SYSTEM) VERSION1.0, Substantially Equivalent on 2006-12-21. Applicant: Boston Scientific Corp.

Clearance details

Applicant: Boston Scientific Corp
Product code: Code IYN
Advisory panel: Radiology
Date received: 2006-11-20
Decision date: 2006-12-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Fremont, CA, US

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Adverse events under product code IYN

product code IYN

Death: 25
Injury: 163
Malfunction: 1,538
Other: 4
Total: 1,730

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.