Cleared Traditional

K163619 - SIGNA PET/MR

K163619 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 54-day FDA review.

K163619 · Ge Medical Systems, LLC · Radiology device
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Feb 2017
Decision
54d
Days
Class 2
Risk

K163619 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 February 14, 2017 after a review of 54 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ge Medical Systems, LLC devices

Submission Details

510(k) Number K163619 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2016
Decision Date February 14, 2017
Days to Decision 54 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
53d faster than avg
Panel avg: 107d · This submission: 54d
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 12
Devices cleared under the same product code (OUO) and FDA review panel - the closest regulatory comparables to K163619.
uPMR 790
K183014 · Shanghai United Imaging Healthcare Co., Ltd. · Feb 2019
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
K142098 · Ge Medical Systems, LLC · Nov 2014
BIOGRAPH MMR
K133226 · Siemens Medical Solutions USA, Inc. · Nov 2013
BIOGRAPH MMR
K103429 · Siemens Medical Solutions USA, Inc. · Jun 2011