Cleared Traditional

K030317 - MODEL 1300GE-64: PEDIATRIC POSITIONER

K030317 is an FDA 510(k) clearance for MODEL 1300GE-64: PEDIATRIC POSITIONER, manufactured by Midwest Rf, LLC. The device is a Class 2 Radiology device with product code MOS cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K030317 · Midwest Rf, LLC · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2003
Decision
54d
Days
Class 2
Risk

K030317 is an FDA 510(k) clearance for the MODEL 1300GE-64: PEDIATRIC POSITIONER. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Midwest Rf, LLC (Hartland, US). The FDA issued a Cleared decision on March 25, 2003 after a review of 54 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 Midwest Rf, LLC devices

FDA 510(k) Submission Details - K030317

510(k) Number K030317 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2003
Decision Date March 25, 2003
Days to Decision 54 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 107d · This submission: 54d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MOS Device Classification - Class 2, Special Controls

Product Code MOS Coil, Magnetic Resonance, Specialty
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 - MOS Coil, Magnetic Resonance, Specialty

All 339
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K030317.
GORE-FLEX MP8 MULTIPURPOSE TORSO ARRAY
K031089 · W.L. Gore & Associates, Inc. · May 2003
PRIMA III TOTALSENSE TORSO COIL
K030371 · Usa Instruments, Inc. · May 2003
GE 3.0T GENERAL PURPOSE FLEX COIL
K030953 · Ge Medical Systems, Inc. · Apr 2003
3.0T TORSO PHASED ARRAY COIL
K030495 · Ge Medical Systems, Inc. · Mar 2003
PREMIER III PHASED ARRAY CTL SPINE COIL
K030042 · Usa Instruments, Inc. · Feb 2003
LEO III TX/RX QUADRATURE KNEE COIL
K023982 · Usa Instruments, Inc. · Feb 2003