Cleared Traditional

K981094 - MEDRAD NEUROVASCULAR COIL

K981094 is the FDA 510(k) clearance for MEDRAD NEUROVASCULAR COIL by Medrad, Inc.. It is a Class 2 Radiology device (product code MOS) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K981094 · Medrad, Inc. · Radiology device
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Jun 1998
Decision
84d
Days
Class 2
Risk

K981094 is an FDA 510(k) clearance for the MEDRAD NEUROVASCULAR COIL. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Medrad, Inc. (Indianola, US). The FDA issued a Cleared decision on June 18, 1998 after a review of 84 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 Medrad, Inc. devices

Submission Details

510(k) Number K981094 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1998
Decision Date June 18, 1998
Days to Decision 84 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
23d faster than avg
Panel avg: 107d · This submission: 84d
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 300
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K981094.
FLOW 7000 PERIPHERAL VASCULAR COIL
K982339 · Usa Instruments, Inc. · Sep 1998
OUTLOOK LARGE PHASED ARRAY NECK COIL
K981959 · Philips Medical Systems (Cleveland), Inc. · Jul 1998
CERVIX COIL LATEX SHEATH
K981406 · Philips Medical Systems (Cleveland), Inc. · Jul 1998
AIRIS MAGNETIC RESONANCE DIAGNOSTIC DEVICE
K980691 · Hitachi Medical Systems America, Inc. · May 1998
MEDRAD ATD-T INTERFACE DEVICE
K974438 · Medrad, Inc. · Apr 1998
PREMIER 7000 CTL SPINE COIL
K980157 · Usa Instruments, Inc. · Apr 1998