MR ENHANCER— 510(k) K994117

Name: FDA 510(k) clearance K994117
Creator: U.S. Food and Drug Administration
Published: 2000-02-04

Substantially Equivalent

I.Z.I. Corp.

FDA 510(k) clearance K994117 for MR ENHANCER, Substantially Equivalent on 2000-02-04. Applicant: I.Z.I. Corp.. Device class: 2.

Clearance details

Applicant: I.Z.I. Corp.
Product code: Code LNH
Device class: Class 2
Regulation: 21 CFR 892.1000
Advisory panel: Radiology
Date received: 1999-12-06
Decision date: 2000-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crofton, MD, US

Download summary PDF View on FDA.gov ↗

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K930752 — CT/MRI TOPOGRAPHIC MARKER1993-11-19

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.