DICOMNET— 510(k) K961451

Substantially Equivalent

Lockheed Martin Communications Systems

FDA 510(k) clearance K961451 for DICOMNET, Substantially Equivalent on 1996-07-03. Applicant: Lockheed Martin Communications Systems.

Clearance details

Applicant
Lockheed Martin Communications Systems
Product code
Code IZI
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Camden, NJ, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code IZI

product code IZI
Death
9
Malfunction
5,312
Total
5,321

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.