MRI EQUIPMENT COVER— 510(k) K993682

Substantially Equivalent

Image-Guided Neurologics, Inc.

FDA 510(k) clearance K993682 for MRI EQUIPMENT COVER, Substantially Equivalent on 2000-01-20. Applicant: Image-Guided Neurologics, Inc..

Clearance details

Applicant: Image-Guided Neurologics, Inc.
Product code: Code LNH
Advisory panel: Radiology
Date received: 1999-11-01
Decision date: 2000-01-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Melbourne, FL, US

Download summary PDF View 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, 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.