Cleared Traditional

K980157 - PREMIER 7000 CTL SPINE COIL

K980157 is the FDA 510(k) clearance for PREMIER 7000 CTL SPINE COIL by Usa Instruments, Inc.. It is a Class 2 Radiology device (product code MOS) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K980157 · Usa Instruments, Inc. · Radiology device
Download Printable Device Report (PDF)
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Apr 1998
Decision
87d
Days
Class 2
Risk

K980157 is an FDA 510(k) clearance for the PREMIER 7000 CTL SPINE 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 April 13, 1998 after a review of 87 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 K980157 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 1998
Decision Date April 13, 1998
Days to Decision 87 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
20d faster than avg
Panel avg: 107d · This submission: 87d
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 K980157.
MEDRAD NEUROVASCULAR COIL
K981094 · Medrad, Inc. · Jun 1998
AIRIS MAGNETIC RESONANCE DIAGNOSTIC DEVICE
K980691 · Hitachi Medical Systems America, Inc. · May 1998
MEDRAD ATD-T INTERFACE DEVICE
K974438 · Medrad, Inc. · Apr 1998
MEDRAD 1.5T PERIPHERAL VASCULAR ARRAY
K974308 · Medrad, Inc. · Jan 1998
MEDRAD 1.5T EXTREMITY ARRAY
K973787 · Medrad, Inc. · Dec 1997
CP BREAST ARRAY COIL/MAGNETOM HARMONY/SYMPHONY SYSTEM
K973630 · Siemens Medical Solutions USA, Inc. · Dec 1997