Cleared Traditional

K223439 - SIGNA Victor

K223439 is an FDA 510(k) clearance for SIGNA Victor, manufactured by Ge Healthcare (Tianjin) Company Limited. The device is a Class 2 Radiology device with product code LNH cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K223439 · Ge Healthcare (Tianjin) Company Limited · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2023
Decision
91d
Days
Class 2
Risk

K223439 is an FDA 510(k) clearance for the SIGNA Victor. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Ge Healthcare (Tianjin) Company Limited (Tianjin, CN). The FDA issued a Cleared decision on February 13, 2023 after a review of 91 days - within the typical 510(k) review window.

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 Ge Healthcare (Tianjin) Company Limited devices

FDA 510(k) Submission Details - K223439

510(k) Number K223439 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2022
Decision Date February 13, 2023
Days to Decision 91 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 107d · This submission: 91d
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 961
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K223439.
Swoop® Portable MR Imaging System™
K230208 · Hyperfine, Inc. · Feb 2023
NEONA 1.5T MRI System
K222259 · Time Medical Limited · Feb 2023
uMR 680
K222755 · Shanghai United Imaging Intelligence Co., Ltd. · Feb 2023
ECHELON Oval V6.2 MRI System
K221619 · Fujifilm Healthcare Corporation · Jan 2023
MR 5300 and MR 7700 R11 MR Systems
K223442 · Philips Medical Systems Nederlands B.V. · Dec 2022
Swoop Portable MR Imaging System
K223247 · Hyperfine, Inc. · Dec 2022