Fusion Bx 2.0— 510(k) K181290

Substantially Equivalent

Focal Healthcare, Inc.

FDA 510(k) clearance K181290 for Fusion Bx 2.0, Substantially Equivalent on 2018-06-15. Applicant: Focal Healthcare, Inc..

Clearance details

Applicant: Focal Healthcare, Inc.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2018-05-16
Decision date: 2018-06-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Toronto, CA

Download summary PDF View on FDA.gov ↗

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.