Cleared Traditional

K213603 - SIGNA Artist Evo

K213603 is the FDA 510(k) clearance for SIGNA Artist Evo by Ge Healthcare (Tianjin) Company Limited. It is a Class 2 Radiology device (product code LNH) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K213603 · Ge Healthcare (Tianjin) Company Limited · Radiology device
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Optimized for regulatory review, auditing and printing
Feb 2022
Decision
88d
Days
Class 2
Risk

K213603 is an FDA 510(k) clearance for the SIGNA Artist Evo. 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 11, 2022 after a review of 88 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 Ge Healthcare (Tianjin) Company Limited devices

Submission Details

510(k) Number K213603 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2021
Decision Date February 11, 2022
Days to Decision 88 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
19d faster than avg
Panel avg: 107d · This submission: 88d
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 Consultant

Ge Healthcare (Ge Medical Systems, LLC)
Glen Sabin

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LNH System, Nuclear Magnetic Resonance Imaging

All 812
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