MRI SYSTEM, MODEL MAGFINDER II / AI 3200— 510(k) K072850

Substantially Equivalent

Advanced Imaging Laboratory

FDA 510(k) clearance K072850 for MRI SYSTEM, MODEL MAGFINDER II / AI 3200, Substantially Equivalent on 2007-11-21. Applicant: Advanced Imaging Laboratory.

Clearance details

Applicant
Advanced Imaging Laboratory
Product code
Code LNH
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Sound Beach, NY, US
Download summary PDFView on FDA.gov ↗

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, 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.