DeviceClearance

EASYVIZ, EASYVIZ SYSTEM, EASYVIZ PACS SYSTEM, EASYVIZ IMAGE AND DATA MANAGEMENT SYSTEM— 510(k) K051809

Substantially Equivalent

Medical Insight A/S

FDA 510(k) clearance K051809 for EASYVIZ, EASYVIZ SYSTEM, EASYVIZ PACS SYSTEM, EASYVIZ IMAGE AND DATA MANAGEMENT SYSTEM, Substantially Equivalent on 2005-08-15. Applicant: Medical Insight A/S. Device class: 2.

Clearance details

Applicant
Medical Insight A/S
Product code
Code LLZ
Device class
Class 2
Regulation
21 CFR 892.2050
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
San Leandro, CA, US
Download summary PDFView 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, through . 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.