HI-STAR MRI IMAGING SYSTEM— 510(k) K964778

Name: FDA 510(k) clearance K964778
Creator: U.S. Food and Drug Administration
Published: 1997-02-24

Substantially Equivalent

Health Images, Inc.

FDA 510(k) clearance K964778 for HI-STAR MRI IMAGING SYSTEM, Substantially Equivalent on 1997-02-24. Applicant: Health Images, Inc.. Device class: 2.

Clearance details

Applicant: Health Images, Inc.
Product code: Code LNH
Device class: Class 2
Regulation: 21 CFR 892.1000
Advisory panel: Radiology
Date received: 1996-11-27
Decision date: 1997-02-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Atlanta, GA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Health Images, Inc.

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K944724 — HEALTH IMAGE INC. HI STAR1995-08-30
K944228 — HEALTH IMAGES, INC. HI-STANDARD1995-07-20
K911746 — H.I.STANDARD CALIBRE UPGRADE1991-08-16
K890092 — HI STANDARD MAGNETIC RESONANCE DIAGNOSTIC DEVICE1989-06-23

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.