Cleared Traditional

K091669 - OPEN MAGNETIC RESONANCE IMAGING SYSTEM, MODEL MPF3000-III

K091669 is an FDA 510(k) clearance for OPEN MAGNETIC RESONANCE IMAGING SYSTEM, manufactured by Xioao Mdt Technology Co, Ltd.. The device is a Class 2 Radiology device with product code LNH cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K091669 · Xioao Mdt Technology Co, Ltd. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2009
Decision
9d
Days
Class 2
Risk

K091669 is an FDA 510(k) clearance for the OPEN MAGNETIC RESONANCE IMAGING SYSTEM, MODEL MPF3000-III. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Xioao Mdt Technology Co, Ltd. (Northbrook, US). The FDA issued a Cleared decision on June 18, 2009 after a review of 9 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 - K091669

510(k) Number K091669 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 2009
Decision Date June 18, 2009
Days to Decision 9 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
98d faster than avg
Panel avg: 107d · This submission: 9d
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

Underwriters Laboratories, Inc.

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.

Regulatory Peers - LNH System, Nuclear Magnetic Resonance Imaging

All 1107
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K091669.
PICA WHOLE BODY MRI SYSTEM
K091580 · Time Medical Limited · Jul 2009
PERFSCAPE
K091444 · Olea Medical · Jul 2009
OPTIMA MR450W
K091536 · Ge Medical Systems, LLC · Jul 2009
SYNGO BREVIS
K090038 · Siemens Medical Solutions USA, Inc. · Apr 2009
I OPEN 0.5T
K090873 · Beijing Wandong Medical Equipment Co., Ltd. · Apr 2009
I_OPEN 0.4T
K090433 · Beijing Wandong Medical Equipment Co., Ltd. · Mar 2009
K091669 · OPEN MAGNETIC RESONANCE IMAGING SYSTEM, MODEL MPF3000-III
Download PDF FDA Summary Xioao Mdt Technology …