VM PACS WITH VM MEDICAL WORKSTATION— 510(k) K141561

Name: FDA 510(k) clearance K141561
Creator: U.S. Food and Drug Administration
Published: 2015-01-16

Substantially Equivalent

Visual Medica

FDA 510(k) clearance K141561 for VM PACS WITH VM MEDICAL WORKSTATION, Substantially Equivalent on 2015-01-16. Applicant: Visual Medica. Device class: 2.

Clearance details

Applicant: Visual Medica
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2014-06-12
Decision date: 2015-01-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ciudad Autonoma De Buenos Aires, AR

Download summary PDF View on FDA.gov ↗

Recent devices under product code LLZ

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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.