Cleared Traditional

SPIRIT III TOTALSENSE CARDIAC COIL (K024187) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K024187 · Usa Instruments, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2003
Decision
47d
Days
Class 2
Risk

K024187 is an FDA 510(k) clearance for the SPIRIT III TOTALSENSE CARDIAC 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 February 4, 2003 after a review of 47 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 Usa Instruments, Inc. devices

Submission Details

510(k) Number K024187 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2002
Decision Date February 04, 2003
Days to Decision 47 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
60d faster than avg
Panel avg: 107d · This submission: 47d
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 92
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K024187.
8 CHANNEL CARDIAC PHASED ARRAY COIL
K032045 · GE Medical Systems · Jul 2003
SENSE BODY COIL
K031095 · Philips Medical Systems (Cleveland), Inc. · Jun 2003
GORE-FLEX MP8 MULTIPURPOSE TORSO ARRAY
K031089 · W.L. Gore & Associates, Inc. · May 2003
GORE 3.0T TORSO ARRAY
K023679 · W.L. Gore & Associates, Inc. · Nov 2002
EXTRA LARGE BODY COIL
K023442 · GE Medical Systems · Nov 2002
8 CHANNEL CARDIAC PHASED ARRAY COIL
K022669 · GE Medical Systems · Sep 2002