Cleared Traditional

K123091 - VISIUS WIRELESS COILS, 1.5T/ VISIUS WIRELESS COILS, 3T

K123091 is an FDA 510(k) clearance for VISIUS WIRELESS COILS, manufactured by Imris, Inc.. The device is a Class 2 Radiology device with product code MOS cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K123091 · Imris, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2012
Decision
86d
Days
Class 2
Risk

K123091 is an FDA 510(k) clearance for the VISIUS WIRELESS COILS, 1.5T/ VISIUS WIRELESS COILS, 3T. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Imris, Inc. (Winnipeg, Mb, CA). The FDA issued a Cleared decision on December 27, 2012 after a review of 86 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.

FDA 510(k) Submission Details - K123091

510(k) Number K123091 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2012
Decision Date December 27, 2012
Days to Decision 86 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
21d faster than avg
Panel avg: 107d · This submission: 86d
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 489
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K123091.
1.5T 16CH FLEX SPEEDER LARGE, 1.5T 16CH FLEX SPEEDER MEDIUM
K123272 · Neocoil, LLC · Mar 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
SENSE HEAD 16 MODEL 800647, SENSE SPINE 16 MODEL 800646
K122897 · Invivo Corporation · Dec 2012
DS ANTERIOR, DS BASE, DS HEAD-NECK, DS HEAD, FLEX (S,M,L)
K123492 · Philips Medical Systems · Dec 2012
DS BREAST 16CH I/T 1.5T DS BREAST 16CH I/T 3.0T
K122646 · Invivo Corporation · Nov 2012