MODEL 700GE1500 CARDIAC VASCULAR COIL FOR G.E. 1.5T SIGNA— 510(k) K933295

Name: FDA 510(k) clearance K933295
Creator: U.S. Food and Drug Administration
Published: 1994-03-17

Substantially Equivalent

Medic, Inc.

FDA 510(k) clearance K933295 for MODEL 700GE1500 CARDIAC VASCULAR COIL FOR G.E. 1.5T SIGNA, Substantially Equivalent on 1994-03-17. Applicant: Medic, Inc.. Device class: 2.

Clearance details

Applicant: Medic, Inc.
Product code: Code LNH
Device class: Class 2
Regulation: 21 CFR 892.1000
Advisory panel: Radiology
Date received: 1993-07-07
Decision date: 1994-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fremont, NE, US

Download summary PDF View on FDA.gov ↗

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K942873 — MODEL #700TO3500 NECK/ABDOMINAL COIL1994-12-02
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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.