Cleared Special

K202238 - SIGNA Artist

K202238 is an FDA 510(k) clearance for SIGNA Artist, manufactured by Ge Healthcare (Tianjin) Company Limited. The device is a Class 2 Radiology device with product code LNH cleared through the Special 510(k) pathway after a 28-day FDA review.

K202238 · Ge Healthcare (Tianjin) Company Limited · Radiology device
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Sep 2020
Decision
28d
Days
Class 2
Risk

K202238 is an FDA 510(k) clearance for the SIGNA Artist. 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 September 4, 2020 after a review of 28 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ge Healthcare (Tianjin) Company Limited devices

FDA 510(k) Submission Details - K202238

510(k) Number K202238 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2020
Decision Date September 04, 2020
Days to Decision 28 days
Submission Type Special
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
79d faster than avg
Panel avg: 107d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 Consultant

Ge Healthcare (Ge Medical System, 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.

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