Cleared Abbreviated

K123272 - 1.5T 16CH FLEX SPEEDER LARGE, 1.5T 16CH FLEX SPEEDER MEDIUM

K123272 is an FDA 510(k) clearance for 1.5T 16CH FLEX SPEEDER LARGE, manufactured by Neocoil, LLC. The device is a Class 2 Radiology device with product code MOS cleared through the Abbreviated 510(k) pathway after a 160-day FDA review.

K123272 · Neocoil, LLC · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2013
Decision
160d
Days
Class 2
Risk

K123272 is an FDA 510(k) clearance for the 1.5T 16CH FLEX SPEEDER LARGE, 1.5T 16CH FLEX SPEEDER MEDIUM. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Neocoil, LLC (Pewaukee, US). The FDA issued a Cleared decision on March 28, 2013 after a review of 160 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Neocoil, LLC devices

FDA 510(k) Submission Details - K123272

510(k) Number K123272 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 2012
Decision Date March 28, 2013
Days to Decision 160 days
Submission Type Abbreviated
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
53d slower than avg
Panel avg: 107d · This submission: 160d
Pathway characteristics
Standards-based clearance path.

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 478
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K123272.
DUOFLEX COIL SUITE (1.5T)
K130706 · Mr Instruments, Inc. · Jul 2013
3T DISTAL COIL, 3T ELBOW COIL, 3T LONG BONE COIL
K130457 · Resonance Innovations, LLC · May 2013
SPINE COIL
K123708 · Usa Paramed Medical Systems, Inc. · Apr 2013
1.5T 4CH LARGE FLEX COIL, 1.5 4CH SMALL FLEX COIL
K123681 · Wipro GE Healthcare Private, Ltd. · Feb 2013
1.5T GEM RT OPEN ARRAY
K123327 · Ge Healthcare Coils (Usa Instruments, Inc.) · Jan 2013
VISIUS WIRELESS COILS, 1.5T/ VISIUS WIRELESS COILS, 3T
K123091 · Imris, Inc. · Dec 2012