LIBERTY 9000 8-CH BREAST COIL WITH DISPOSABLE BIOPSY PLATE— 510(k) K041695

Name: FDA 510(k) clearance K041695
Creator: U.S. Food and Drug Administration
Published: 2004-07-23

Substantially Equivalent

Usa Instruments, Inc.

FDA 510(k) clearance K041695 for LIBERTY 9000 8-CH BREAST COIL WITH DISPOSABLE BIOPSY PLATE, Substantially Equivalent on 2004-07-23. Applicant: Usa Instruments, Inc.. Device class: 2.

Clearance details

Applicant: Usa Instruments, Inc.
Product code: Code LNH
Device class: Class 2
Regulation: 21 CFR 892.1000
Advisory panel: Radiology
Date received: 2004-06-22
Decision date: 2004-07-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Aurora, OH, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LNH

product code LNH

Death: 11
Injury: 670
Malfunction: 1,460
Other: 2
Total: 2,143

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.