BIOGRAPH One
FDA 510(k) K253023 · Siemens Healthineers AG
510(k) numberK253023
Submission
- Device name
- BIOGRAPH One
- Applicant
- Siemens Healthineers AG
Forchheim, DE - Received
- September 19, 2025
- Decision date
- January 15, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OUO – Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.1200
- Specialty
- Radiology
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.
Other 510(k)s with product code OUO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253963 | Cubresa BrainPETOUO · Traditional | Cubresa, Inc. | 07/17/2026SE |
| K234154 | uPMR 790OUO · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 05/24/2024SE |
| K222540 | uPMR 790OUO · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 11/14/2022SE |
| K213709 | Signa Pet/MrOUO · Traditional | Ge Medical Systems, LLC | 01/20/2022SE |
| K200213 | Biograph mMR with syngo MR E11P-AP01 system softwareOUO · Traditional | Siemens Medical Solutions USA, Inc. | 05/11/2020SE |
| K192672 | uPMR 790OUO · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 11/20/2019SE |
| K183014 | uPMR 790OUO · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 02/27/2019SE |
| K172531 | Biograph mMR with mMR Angio Transfer OptionOUO · Traditional | Siemens Medical Solutions USA, Inc. | 11/14/2017SE |
| K163234 | Biograph mMR with syngo MR E11P system softwareOUO · Traditional | Siemens Medical Solutions USA, Inc. | 02/28/2017SE |
| K163619 | Signa Pet/MrOUO · Traditional | Ge Medical Systems, LLC | 02/14/2017SE |
More from Ge Medical Systems, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K260852 | MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureLNH · Traditional | 07/31/2026SE |
| K253690 | LungMapsQIH · Traditional | 06/15/2026SE |
| K253495 | syngo.MR Applications (VB80)LLZ · Traditional | 11/20/2025SE |
| K251059 | Syngo Carbon Clinicals (VA41)QIH · Traditional | 10/24/2025SE |
| K241898 | Symbia SPECT and SPECT/CT SystemsKPS · Special | 07/26/2024SE |
| K183575 | ACUSON S3000, S2000 Diagnostic Ultrasound SystemIYN · Traditional | 03/20/2019SE |
Questions and answers
When was BIOGRAPH One cleared by the FDA?
BIOGRAPH One (K253023) received a 510(k) decision of Substantially Equivalent on January 15, 2026, 118 days after the submission was received.
What is the product code of K253023?
The FDA product code is OUO – Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance, a Class II (moderate risk) device regulated under 21 CFR 892.1200.