Cleared Traditional

K162177 - dS FootAnkle I6CH 1.5T Coil

K162177 is an FDA 510(k) clearance for dS FootAnkle I6CH 1.5T Coil, manufactured by Invivo Corporation. The device is a Class 2 Radiology device with product code MOS cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K162177 · Invivo Corporation · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2016
Decision
41d
Days
Class 2
Risk

K162177 is an FDA 510(k) clearance for the dS FootAnkle I6CH 1.5T Coil. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Invivo Corporation (Florida, US). The FDA issued a Cleared decision on September 14, 2016 after a review of 41 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 Invivo Corporation devices

FDA 510(k) Submission Details - K162177

510(k) Number K162177 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2016
Decision Date September 14, 2016
Days to Decision 41 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 107d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MOS Coil, Magnetic Resonance, Specialty

All 311
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K162177.
Breast BI 7 MR Coil 1.5T Mammavention
K180123 · Noras Mri Products GmbH · Feb 2018
16ch T/R Hand Wrist Coil
K173469 · Quality Electrodynamics, LLC · Jan 2018
TRILLIUM Oval Head Coil 32
K162079 · Hitachi Medical Systems America, Inc. · Sep 2016
1.5T and 3.0T 16 CH GE Shoulder Coils
K162001 · Invivo Corporation · Aug 2016
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