Cleared Traditional

K211180 - Liver Suite

K211180 is an FDA 510(k) clearance for Liver Suite, manufactured by GE Medical Systems SCS. The device is a Class 2 Radiology device with product code JAK cleared through the Traditional 510(k) pathway after a 377-day FDA review.

K211180 · GE Medical Systems SCS · Radiology device
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May 2022
Decision
377d
Days
Class 2
Risk

K211180 is an FDA 510(k) clearance for the Liver Suite. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by GE Medical Systems SCS (Buc, FR). The FDA issued a Cleared decision on May 2, 2022 after a review of 377 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1750 - 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. Elevated predicate reliance profile. 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 Medical Systems SCS devices

FDA 510(k) Submission Details - K211180

510(k) Number K211180 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2021
Decision Date May 02, 2022
Days to Decision 377 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
270d slower than avg
Panel avg: 107d · This submission: 377d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAK Device Classification - Class 2, Special Controls

Product Code JAK System, X-ray, Tomography, Computed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1750
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.

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