Cleared Traditional

K972205 - ALPHA 7000 QUADRATURE WRIST COIL

K972205 is the FDA 510(k) clearance for ALPHA 7000 QUADRATURE WRIST COIL by Usa Instruments, Inc.. It is a Class 2 Radiology device (product code MOS) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K972205 · Usa Instruments, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1997
Decision
85d
Days
Class 2
Risk

K972205 is an FDA 510(k) clearance for the ALPHA 7000 QUADRATURE WRIST COIL. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Usa Instruments, Inc. (Highland Heights, US). The FDA issued a Cleared decision on September 5, 1997 after a review of 85 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 K972205 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1997
Decision Date September 05, 1997
Days to Decision 85 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
22d faster than avg
Panel avg: 107d · This submission: 85d
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 K972205.
CP BREAST ARRAY COIL/MAGNETOM HARMONY/SYMPHONY SYSTEM
K973630 · Siemens Medical Solutions USA, Inc. · Dec 1997
MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
K972296 · Ge Medical Systems, Inc. · Sep 1997
2T PRESTIGE(100-6321-0107)/PRIVILEGE(100-6326-0102)/GYREX V-EP(100-6327-0101)
K972592 · Elscint, Inc. · Sep 1997
INSIGHT 7000 PHASED ARRAY TORSO COIL
K972340 · Usa Instruments, Inc. · Aug 1997
CARDIAC PHASED ARRAY COIL
K971667 · GE Medical Systems · Jul 1997
SIGNA SP CROWN COILS (NUMBERS 1 THROUGH 3)
K964969 · GE Medical Systems · Jun 1997