Cleared Traditional

K193176 - uMR 780

K193176 is the FDA 510(k) clearance for uMR 780 by Shanghai United Imaging Healthcare Co., Ltd.. It is a Class 2 Radiology device (product code LNH) cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K193176 · Shanghai United Imaging Healthcare Co., Ltd. · Radiology device
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May 2020
Decision
169d
Days
Class 2
Risk

K193176 is an FDA 510(k) clearance for the uMR 780. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Shanghai United Imaging Healthcare Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on May 5, 2020 after a review of 169 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 Shanghai United Imaging Healthcare Co., Ltd. devices

Submission Details

510(k) Number K193176 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 2019
Decision Date May 05, 2020
Days to Decision 169 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
62d slower than avg
Panel avg: 107d · This submission: 169d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 812
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K193176.
Resoundant Acoustic Driver System
K201389 · Resoundant, Inc. · Jul 2020
uMR570
K201540 · Shanghai United Imaging Healthcare Co., Ltd. · Jul 2020
Vantage Orian 1.5T, MRT-1550, V6.0
K193021 · Canon Medical Systems Corporation · Jun 2020
Evry
K200327 · Synaptive Medical, Inc. · Apr 2020
uMR 570
K200024 · Shanghai United Imaging Healthcare Co., Ltd. · Apr 2020
Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR Systems
K193215 · Philips Medical Systems Nederland B.V. · Apr 2020