Cleared Traditional

K142098 - SIGNA PET/MR

K142098 is the FDA 510(k) clearance for SIGNA PET/MR by Ge Medical Systems, LLC. It is a Class 2 Radiology device (product code OUO) cleared through the Traditional 510(k) pathway after a 115-day FDA review.

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.

View all Ge Medical Systems, LLC devices

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 107d · This submission: 115d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Radiology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT01986985 Completed Interventional Industry-sponsored

Comparison of 18F FDG PET/CT TO PET MRI

58
Patients (actual)
2
Sites
Open label
Masking
Condition studied Any Condition With a Clinical Indication for PET/CT Exam
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator Roee Lazebnik, MD
Sponsor GE Healthcare (industry)
Started 2014-01-01 → Primary completion 2014-06-01 → Completed 2014-07-01
Primary outcome
PET/MR Images Clinical Usefulness
View full study on ClinicalTrials.gov

Regulatory Peers - OUO Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance

All 12
Devices cleared under the same product code (OUO) and FDA review panel - the closest regulatory comparables to K142098.
Biograph mMR with mMR Angio Transfer Option
K172531 · Siemens Medical Solutions USA, Inc. · Nov 2017
Biograph mMR with syngo MR E11P system software
K163234 · Siemens Medical Solutions USA, Inc. · Feb 2017
SIGNA PET/MR
K163619 · Ge Medical Systems, LLC · Feb 2017
BIOGRAPH MMR
K133226 · Siemens Medical Solutions USA, Inc. · Nov 2013
BIOGRAPH MMR
K103429 · Siemens Medical Solutions USA, Inc. · Jun 2011