510(k) K253023
K253023 is an FDA 510(k) premarket notification submitted by Siemens Healthineers AG for the device "BIOGRAPH One". The FDA issued a decision of Substantially Equivalent on January 15, 2026. The device falls under product code OUO (Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance), a Class II device regulated under 21 CFR 892.1200. Siemens Healthineers AG has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 15, 2026
- Date Received
- September 19, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
- Device Class
- Class II
- Regulation Number
- 892.1200
- Review Panel
- RA
- Submission Type
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.