Cleared Traditional

K964678 - PHASED ARRAY NECK COIL

K964678 is the FDA 510(k) clearance for PHASED ARRAY NECK COIL by Philips Medical Systems (Cleveland), Inc.. It is a Class 2 Radiology device (product code MOS) cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K964678 · Philips Medical Systems (Cleveland), Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
82d
Days
Class 2
Risk

K964678 is an FDA 510(k) clearance for the PHASED ARRAY NECK COIL. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Philips Medical Systems (Cleveland), Inc. (Highland Heights, US). The FDA issued a Cleared decision on February 11, 1997 after a review of 82 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 Philips Medical Systems (Cleveland), Inc. devices

Submission Details

510(k) Number K964678 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1996
Decision Date February 11, 1997
Days to Decision 82 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
25d faster than avg
Panel avg: 107d · This submission: 82d
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 299
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K964678.
MRP-7000/AIRIS QD C-SPINE COIL (P/N MR-QCSC-42,MR-QCSC-52)
K971016 · Hitachi Medical Systems America, Inc. · Jun 1997
MODEL 675GE-64 PERIPHERAL VASCULAR COIL CONSISTING OF MODEL 665GE-64: LOWER EXTREMITY FLEXIBLE ARRAY AND MODEL 538GE-64:
K964813 · Medical Advances, Inc. · Feb 1997
MODELS EXL AND EXS EXTREMITY COIL SET
K964668 · Mri Devices Corp. · Feb 1997
MEDRAD PHASED ARRAY 1.5T SHOULDER IMAGING SURGACE COIL
K964854 · Medrad, Inc. · Feb 1997
PHASED ARRAY SHOULDER COIL
K963356 · Philips Medical Systems (Cleveland), Inc. · Nov 1996
ARRAY OPEN BREAST COIL (MODEL OBC-63 PA)
K961525 · Mri Devices Corp. · Sep 1996