Cleared Traditional

K162079 - TRILLIUM Oval Head Coil 32

K162079 is an FDA 510(k) clearance for TRILLIUM Oval Head Coil 32, manufactured by Hitachi Medical Systems America, Inc.. The device is a Class 2 Radiology device with product code MOS cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K162079 · Hitachi Medical Systems America, Inc. · Radiology device
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Sep 2016
Decision
51d
Days
Class 2
Risk

K162079 is an FDA 510(k) clearance for the TRILLIUM Oval Head Coil 32. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Hitachi Medical Systems America, Inc. (Twinsburg, US). The FDA issued a Cleared decision on September 16, 2016 after a review of 51 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 Hitachi Medical Systems America, Inc. devices

FDA 510(k) Submission Details - K162079

510(k) Number K162079 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2016
Decision Date September 16, 2016
Days to Decision 51 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
56d faster than avg
Panel avg: 107d · This submission: 51d
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.

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All 411
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