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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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 Consultant

Regulatory Technology Services, LLC

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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K042948 · I OPEN 0.36 T-MAGNETIC RESONANCE IMAGING SYSTEM
Download PDF FDA Summary Wandong Medical