ALI 3D TOOL MODULE FOR MEDICAL IMAGES— 510(k) K003762

Substantially Equivalent

A.L.I. Technologies, Inc.

FDA 510(k) clearance K003762 for ALI 3D TOOL MODULE FOR MEDICAL IMAGES, Substantially Equivalent on 2001-02-28. Applicant: A.L.I. Technologies, Inc..

Clearance details

Applicant
A.L.I. Technologies, Inc.
Product code
Code LLZ
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Richmond, B.C., CA
Download summary PDFView on FDA.gov ↗

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.