Cleared Traditional

uPMR 790

K183014 · Shanghai United Imaging Healthcare Co., Ltd. · Radiology

Feb 2019

Decision

119d

Days

Class 2

Risk

About This 510(k) Submission

K183014 is an FDA 510(k) clearance for the uPMR 790, a Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance (Class II — Special Controls, product code OUO), submitted by Shanghai United Imaging Healthcare Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on February 27, 2019, 119 days after receiving the submission on October 31, 2018. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1200.

Submission Details

510(k) Number	K183014 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 31, 2018
Decision Date	February 27, 2019
Days to Decision	119 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.