IVA (MXA II SOFTWARE OPTION)— 510(k) K060111

Substantially Equivalent

Hologic, Inc.

FDA 510(k) clearance K060111 for IVA (MXA II SOFTWARE OPTION), Substantially Equivalent on 2006-04-24. Applicant: Hologic, Inc..

Clearance details

Applicant: Hologic, Inc.
Product code: Code KGI
Advisory panel: Radiology
Date received: 2006-01-17
Decision date: 2006-04-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bedford, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KGI

product code KGI

Other: 1
Total: 1

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.