Cleared Traditional

K142098 - SIGNA PET/MR (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K142098 · Ge Medical Systems, LLC · Radiology device
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Nov 2014
Decision
115d
Days
Class 2
Risk

K142098 is an FDA 510(k) clearance for the SIGNA PET/MR. Classified as Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance (product code OUO), Class II - Special Controls.

Submitted by Ge Medical Systems, LLC (Waukesha, US). The FDA issued a Cleared decision on November 24, 2014 after a review of 115 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1200 - 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.

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Submission Details

510(k) Number K142098 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2014
Decision Date November 24, 2014
Days to Decision 115 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
8d slower than avg
Panel avg: 107d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OUO Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1200
Definition Imager That Generates Both Both Magnetic Resonance (mr) And Positron Emission Tomography (pet) Images And Provides Registration And Fusion Of These Images. Pet And Mr Images Can Be Acquired Either Simultaneously Or Sequentially. Anatomical Mr Images Are Used For Pet Attenuation Correction.
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 - OUO Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance

All 13
Devices cleared under the same product code (OUO) and FDA review panel - the closest regulatory comparables to K142098.
BIOGRAPH One
K253023 · Siemens Healthineers AG · Jan 2026
uPMR 790
K234154 · Shanghai United Imaging Healthcare Co., Ltd. · May 2024
uPMR 790
K222540 · Shanghai United Imaging Healthcare Co., Ltd. · Nov 2022
SIGNA PET/MR
K213709 · Ge Medical Systems, LLC · Jan 2022