Cleared Traditional

BIOGRAPH One

K253023 · Siemens Healthineers AG · Radiology

Jan 2026

Decision

118d

Days

Class 2

Risk

About This 510(k) Submission

K253023 is an FDA 510(k) clearance for the BIOGRAPH One, a Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance (Class II — Special Controls, product code OUO), submitted by Siemens Healthineers AG (Forchheim, DE). The FDA issued a Cleared decision on January 15, 2026, 118 days after receiving the submission on September 19, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1200.

Submission Details

510(k) Number	K253023 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 19, 2025
Decision Date	January 15, 2026
Days to Decision	118 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.