Cleared Traditional

K030371 - PRIMA III TOTALSENSE TORSO COIL

K030371 is an FDA 510(k) clearance for PRIMA III TOTALSENSE TORSO COIL, manufactured by Usa Instruments, Inc.. The device is a Class 2 Radiology device with product code MOS cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K030371 · Usa Instruments, Inc. · Radiology device
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May 2003
Decision
90d
Days
Class 2
Risk

K030371 is an FDA 510(k) clearance for the PRIMA III TOTALSENSE TORSO COIL. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Usa Instruments, Inc. (Aurora, US). The FDA issued a Cleared decision on May 5, 2003 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Usa Instruments, Inc. devices

Submission Details

510(k) Number K030371 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 2003
Decision Date May 05, 2003
Days to Decision 90 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 107d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 311
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K030371.
GE 1.5T 8 CHANNEL TORSO COIL
K031209 · Ge Medical Systems, Inc. · May 2003
MODIFICATION TO PREMIER III PHASED ARRAY CTL SPINE COIL
K031056 · Usa Instruments, Inc. · May 2003
GORE-FLEX MP8 MULTIPURPOSE TORSO ARRAY
K031089 · W.L. Gore & Associates, 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