Cleared Traditional

K211980 - SIGNA Prime

K211980 is the FDA 510(k) clearance for SIGNA Prime 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 205-day FDA review.

K211980 · Ge Healthcare (Tianjin) Company Limited · Radiology device
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Jan 2022
Decision
205d
Days
Class 2
Risk

K211980 is an FDA 510(k) clearance for the SIGNA Prime. 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 January 16, 2022 after a review of 205 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 Ge Healthcare (Tianjin) Company Limited devices

Submission Details

510(k) Number K211980 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 2021
Decision Date January 16, 2022
Days to Decision 205 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
98d slower than avg
Panel avg: 107d · This submission: 205d
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.

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