Cleared Traditional

K964969 - SIGNA SP CROWN COILS (NUMBERS 1 THROUGH 3)

K964969 is an FDA 510(k) clearance for SIGNA SP CROWN COILS (NUMBERS 1 THROUGH 3), manufactured by GE Medical Systems. The device is a Class 2 Radiology device with product code MOS cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K964969 · GE Medical Systems · Radiology device
Download Printable Device Report (PDF)
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Jun 1997
Decision
196d
Days
Class 2
Risk

K964969 is an FDA 510(k) clearance for the SIGNA SP CROWN COILS (NUMBERS 1 THROUGH 3). Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by GE Medical Systems (Waukesha, US). The FDA issued a Cleared decision on June 26, 1997 after a review of 196 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 GE Medical Systems devices

FDA 510(k) Submission Details - K964969

510(k) Number K964969 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1996
Decision Date June 26, 1997
Days to Decision 196 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
89d slower than avg
Panel avg: 107d · This submission: 196d
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 312
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K964969.
ALPHA 7000 QUADRATURE WRIST COIL
K972205 · Usa Instruments, Inc. · Sep 1997
INSIGHT 7000 PHASED ARRAY TORSO COIL
K972340 · Usa Instruments, Inc. · Aug 1997
CARDIAC PHASED ARRAY COIL
K971667 · GE Medical Systems · Jul 1997
LEO 7000 QUADRATURE KNEE COIL
K971246 · Usa Instruments, Inc. · Jun 1997
MODEL HNC NEUROVASCULAR ARRAY COIL
K970868 · Mri Devices Corp. · Jun 1997
MRP-7000/AIRIS QD C-SPINE COIL (P/N MR-QCSC-42,MR-QCSC-52)
K971016 · Hitachi Medical Systems America, Inc. · Jun 1997