LMS-LIVER— 510(k) K071241

Name: FDA 510(k) clearance K071241
Creator: U.S. Food and Drug Administration
Published: 2007-06-08

Substantially Equivalent

Median Technologies

FDA 510(k) clearance K071241 for LMS-LIVER, Substantially Equivalent on 2007-06-08. Applicant: Median Technologies. Device class: 2.

Clearance details

Applicant: Median Technologies
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2007-05-03
Decision date: 2007-06-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Winchester, MA, US

Download summary PDF View on FDA.gov ↗

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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.