Cleared Traditional

K974438 - MEDRAD ATD-T INTERFACE DEVICE

K974438 is an FDA 510(k) clearance for MEDRAD ATD-T INTERFACE DEVICE, manufactured by Medrad, Inc.. The device is a Class 2 Radiology device with product code MOS cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K974438 · Medrad, Inc. · Radiology device
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Apr 1998
Decision
157d
Days
Class 2
Risk

K974438 is an FDA 510(k) clearance for the MEDRAD ATD-T INTERFACE DEVICE. 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 April 30, 1998 after a review of 157 days - an extended review 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: 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 Medrad, Inc. devices

FDA 510(k) Submission Details - K974438

510(k) Number K974438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 1997
Decision Date April 30, 1998
Days to Decision 157 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
50d slower than avg
Panel avg: 107d · This submission: 157d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MOS Device Classification - Class 2, Special Controls

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 427
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K974438.
CERVIX COIL LATEX SHEATH
K981406 · Philips Medical Systems (Cleveland), Inc. · Jul 1998
MEDRAD NEUROVASCULAR COIL
K981094 · Medrad, Inc. · Jun 1998
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K980691 · Hitachi Medical Systems America, Inc. · May 1998
PREMIER 7000 CTL SPINE COIL
K980157 · Usa Instruments, Inc. · Apr 1998
MEDRAD 1.5T PERIPHERAL VASCULAR ARRAY
K974308 · Medrad, Inc. · Jan 1998
MEDRAD 1.5T EXTREMITY ARRAY
K973787 · Medrad, Inc. · Dec 1997