Cleared Traditional

K163619 - SIGNA PET/MR (FDA 510(k) Clearance)

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

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
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 13
Devices cleared under the same product code (OUO) and FDA review panel - the closest regulatory comparables to K163619.
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