Cleared Traditional

Biograph mMR with syngo MR E11P-AP01 system software

K200213 · Siemens Medical Solutions USA, Inc. · Radiology

May 2020

Decision

104d

Days

Class 2

Risk

About This 510(k) Submission

K200213 is an FDA 510(k) clearance for the Biograph mMR with syngo MR E11P-AP01 system software, a Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance (Class II — Special Controls, product code OUO), submitted by Siemens Medical Solutions USA, Inc. (Malvern, US). The FDA issued a Cleared decision on May 11, 2020, 104 days after receiving the submission on January 28, 2020. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1200.

Submission Details

510(k) Number	K200213 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 28, 2020
Decision Date	May 11, 2020
Days to Decision	104 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.