Cleared Traditional

K243122 - uMR Omega

K243122 is an FDA 510(k) clearance for uMR Omega, manufactured by Shanghai United Imaging Healthcare Co., Ltd.. The device is a Class 2 Radiology device with product code LNH cleared through the Traditional 510(k) pathway after a 233-day FDA review.

K243122 · Shanghai United Imaging Healthcare Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2025
Decision
233d
Days
Class 2
Risk

K243122 is an FDA 510(k) clearance for the uMR Omega. 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 21, 2025 after a review of 233 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

FDA 510(k) Submission Details - K243122

510(k) Number K243122 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2024
Decision Date May 21, 2025
Days to Decision 233 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
126d slower than avg
Panel avg: 107d · This submission: 233d
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 956
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K243122.
Sonic DL
K243667 · Ge Medical Systems, LLC · Jun 2025
Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR System
K251397 · Philips Medical Systems Nederland B.V. · Jun 2025
Swoop® Portable MR Imaging® System (V2)
K250236 · Hyperfine, Inc. · May 2025
Swoop® Portable MR Imaging® System
K251276 · Hyperfine, Inc. · May 2025
SIGNA Prime Elite
K250379 · Ge Medical Systems, LLC · Mar 2025
SureWave Elastography (Q7000225)
K242006 · Quality Electrodynamics, LLC · Feb 2025