# K253023: BIOGRAPH One

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthineers AG
- Decided: Jan 15, 2026 after 118 days
- Product code: OUO (Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K971684 (1997). 55 ancestors in all.
No later device cites it as a predicate yet.
6 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200213: Biograph mMR with syngo MR E11P-AP01 system software, Siemens Medical Solutions USA, Inc. (2020) Summary page 6.

## Indications for use
Magnetic Resonance Imaging (MRI) is a noninvasive technique used for diagnostic imaging. MRI with its soft tissue contrast capability enables the healthcare professional to differentiate between various soft tissues, for example, fat, water, and muscle, but can also visualize bone structures. Depending on the region of interest, contrast agents may be used. The MR system may also be used for imaging during interventional procedures and radiation therapy planning. The PET images and measures the distribution of PET radiopharmaceuticals in humans to aid the physician in determining various metabolic (molecular) and physiologic functions within the human body for evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders, and cancer. The integrated system utilizes the MRI for radiation-free attenuation correction maps for PET studies. The integrated system provides inherent anatomical reference for the fused MR and PET images due to precisely aligned MR and PET image coordinate systems.

Source page: https://510kreport.com/device/K253023
Methodology: https://510kreport.com/methodology