I OPEN 0.36 T-MAGNETIC RESONANCE IMAGING SYSTEM— 510(k) K042948

Name: FDA 510(k) clearance K042948
Creator: U.S. Food and Drug Administration
Published: 2004-11-03

Substantially Equivalent

Wandong Medical

FDA 510(k) clearance K042948 for I OPEN 0.36 T-MAGNETIC RESONANCE IMAGING SYSTEM, Substantially Equivalent on 2004-11-03. Applicant: Wandong Medical. Device class: 2.

Clearance details

Applicant: Wandong Medical
Product code: Code LNH
Device class: Class 2
Regulation: 21 CFR 892.1000
Advisory panel: Radiology
Date received: 2004-10-26
Decision date: 2004-11-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beijing, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code LNH

view all

K261283 — APERTO Lucent MRI System2026-09-16
K261758 — Embrace Vision Neonatal MRI System2026-09-16
K260758 — MAGNETOM Free.Max; MAGNETOM Free.Star2026-09-01
K262622 — Swoop® Portable MR Imaging® System2026-08-19
K254250 — MagicScan-1.5, GreenMR Serenity 1.5T2026-08-17

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.