Cleared Traditional

SIGNA PET/MR

K213709 · Ge Medical Systems, LLC · Radiology

Jan 2022

Decision

57d

Days

Class 2

Risk

About This 510(k) Submission

K213709 is an FDA 510(k) clearance for the SIGNA PET/MR, a Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance (Class II — Special Controls, product code OUO), submitted by Ge Medical Systems, LLC (Waukesha, US). The FDA issued a Cleared decision on January 20, 2022, 57 days after receiving the submission on November 24, 2021. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1200.

Submission Details

510(k) Number	K213709 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 24, 2021
Decision Date	January 20, 2022
Days to Decision	57 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF

Device Classification

Product Code	OUO — Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
Device Class	Class II — 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.