Cleared Traditional

K042948 - I OPEN 0.36 T-MAGNETIC RESONANCE IMAGING SYSTEM

K042948 is an FDA 510(k) clearance for I OPEN 0.36 T-MAGNETIC RESONANCE IMAGIN..., manufactured by Wandong Medical. The device is a Class 2 Radiology device with product code LNH cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K042948 · Wandong Medical · Radiology device
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Nov 2004
Decision
8d
Days
Class 2
Risk

K042948 is an FDA 510(k) clearance for the I OPEN 0.36 T-MAGNETIC RESONANCE IMAGING SYSTEM. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Wandong Medical (Beijing, CN). The FDA issued a Cleared decision on November 3, 2004 after a review of 8 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1000 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Wandong Medical devices

FDA 510(k) Submission Details - K042948

510(k) Number K042948 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 2004
Decision Date November 03, 2004
Days to Decision 8 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 107d · This submission: 8d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

LNH Device Classification - Class 2, Special Controls

Product Code LNH System, Nuclear Magnetic Resonance Imaging
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1000
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - LNH System, Nuclear Magnetic Resonance Imaging

All 927
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