Radiology
BIOGRAPH One
Siemens Healthineers AG
FDA-cleared AI medical device
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.
FDA Submission Metadata
- Submission number
- K253023
- Decision date
- January 2026
- FDA panel
- Radiology
- Product code
- OUO
This entry is sourced from the FDA AI/ML-Enabled Medical Devices list. No editorial review yet — the catalogue may add a deeper review of this device in future.
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