Devices · Siemens Healthineers AG

BIOGRAPH One

Siemens Healthineers AG is listed for BIOGRAPH One (K253023). The FDA list gives January 15, 2026 as the date of the final decision. The lead panel is Radiology, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code OUO as “Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance”: 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. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253023

Official FDA database record

Date of final decision

January 15, 2026

Company on the FDA list

Siemens Healthineers AG

Lead panel

Radiology

Primary product code

OUO

openFDA device name for the code

Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance

Device class

2

Regulation number

892.1200

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary