Cleared Traditional

K945665 - FLEXART(TM) QD C-SPINE COIL

K945665 is the FDA 510(k) clearance for FLEXART(TM) QD C-SPINE COIL by Toshiba America Mri, Inc.. It is a Class 2 Radiology device (product code LNH) cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K945665 · Toshiba America Mri, Inc. · Radiology device
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Apr 1995
Decision
140d
Days
Class 2
Risk

K945665 is an FDA 510(k) clearance for the FLEXART(TM) QD C-SPINE COIL. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Toshiba America Mri, Inc. (S. San Francisco, US). The FDA issued a Cleared decision on April 6, 1995 after a review of 140 days - within the typical 510(k) review window.

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 Toshiba America Mri, Inc. devices

Submission Details

510(k) Number K945665 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1994
Decision Date April 06, 1995
Days to Decision 140 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
33d slower than avg
Panel avg: 107d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LNH System, Nuclear Magnetic Resonance Imaging
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 - LNH System, Nuclear Magnetic Resonance Imaging

All 817
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K945665.
MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
K950973 · GE Medical Systems · May 1995
MRT-50 QD BODY COIL
K945875 · Toshiba America Mri, Inc. · Apr 1995
ECHO PLANAR IMAGING I
K945828 · Philips Medical Systems (Cleveland), Inc. · Apr 1995
MRT-35A UPGRADE 8.0CD
K945798 · Toshiba America Mri, Inc. · Apr 1995
PHASED ARRAY SHOULDER COIL, QUADRATURE SHOULDER COIL
K945778 · Medical Advances, Inc. · Mar 1995
STRATIS
K945386 · Hitachi Medical Systems America, Inc. · Mar 1995