Cleared Traditional

K190668 - Encompass 15 Channel Head Coil

K190668 is an FDA 510(k) clearance for Encompass 15 Channel Head Coil, manufactured by Qfix. The device is a Class 2 Radiology device with product code MOS cleared through the Traditional 510(k) pathway after a 178-day FDA review.

K190668 · Qfix · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2019
Decision
178d
Days
Class 2
Risk

K190668 is an FDA 510(k) clearance for the Encompass 15 Channel Head Coil, 3T. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Qfix (Avondale, US). The FDA issued a Cleared decision on September 9, 2019 after a review of 178 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 Qfix devices

FDA 510(k) Submission Details - K190668

510(k) Number K190668 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2019
Decision Date September 09, 2019
Days to Decision 178 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
71d slower than avg
Panel avg: 107d · This submission: 178d
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 K190668.
Flex Body Speeder
K200477 · Quality Electrodynamics, LLC · Apr 2020
1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support
K191539 · Rapid Biomedical GmbH · Jan 2020
Flex Body SPEEDER
K193140 · Quality Electrodynamics, LLC · Jan 2020
3T 32 Channel Head Coil
K182737 · Nova Medical, Inc. · Apr 2019
Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular Joint Coil – 4, Infant Coil – 24, Cardiac Coil – 24, Foot & Ankle Coil - 24
K183186 · Shanghai United Imaging Healthcare Co., Ltd. · Feb 2019
Contour 24
K183111 · Quality Electrodynamics, LLC · Dec 2018