Cleared Traditional

K142734 - TRILLIUM Oval MR System

K142734 is an FDA 510(k) clearance for TRILLIUM Oval MR System, manufactured by Hitachi Medical Systems America, Inc.. The device is a Class 2 Radiology device with product code LNH cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K142734 · Hitachi Medical Systems America, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2015
Decision
160d
Days
Class 2
Risk

K142734 is an FDA 510(k) clearance for the TRILLIUM Oval MR System. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Hitachi Medical Systems America, Inc. (Twinsburg, US). The FDA issued a Cleared decision on March 2, 2015 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 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 Hitachi Medical Systems America, Inc. devices

FDA 510(k) Submission Details - K142734

510(k) Number K142734 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2014
Decision Date March 02, 2015
Days to Decision 160 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
53d slower than avg
Panel avg: 107d · This submission: 160d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LNH Device Classification - Class 2, Special Controls

Product Code LNH System, Nuclear Magnetic Resonance Imaging
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 - LNH System, Nuclear Magnetic Resonance Imaging

All 965
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K142734.
Vantage Titan 3T
K143008 · Toshibamedical Systems Corporation · Apr 2015
O-MAR
K143253 · Philips Medical Systems Nederland B.V. · Apr 2015
mDIXON XD
K143128 · Philips Medical Systems Nederlands B.V. · Mar 2015
SIGNA Creator, SIGNA Explorer
K143251 · Ge Healthcare (Ge Medical Systems, LLC) · Feb 2015
ECHOSTAR COMFORT 1.5T MRI
K141945 · Alltech Medical Systems America, Inc. · Feb 2015
RTHawk, HeartVista Workstation with RTHawk
K142997 · Heartvista, Inc. · Dec 2014