Cleared Traditional

K123681 - 1.5T 4CH LARGE FLEX COIL, 1.5 4CH SMALL FLEX COIL

K123681 is an FDA 510(k) clearance for 1.5T 4CH LARGE FLEX COIL, manufactured by Wipro GE Healthcare Private, Ltd.. The device is a Class 2 Radiology device with product code MOS cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K123681 · Wipro GE Healthcare Private, Ltd. · Radiology device
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Feb 2013
Decision
84d
Days
Class 2
Risk

K123681 is an FDA 510(k) clearance for the 1.5T 4CH LARGE FLEX COIL, 1.5 4CH SMALL FLEX COIL. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Wipro GE Healthcare Private, Ltd. (Bangalore, IN). The FDA issued a Cleared decision on February 22, 2013 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 Wipro GE Healthcare Private, Ltd. devices

FDA 510(k) Submission Details - K123681

510(k) Number K123681 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 2012
Decision Date February 22, 2013
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.

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 485
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K123681.
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