BIOGRAPH One
510(k) K253023
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK253023 | Date15 Jan 2026 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- OUO
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1200
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Biograph One is a Tomographic Imager Combining Emission Computed Tomography with Nuclear Magnetic Resonance (PET/MR), designed for hybrid imaging applications in radiology. It integrates positron emission tomography (PET) and magnetic resonance imaging (MRI) into a single system, enabling simultaneous acquisition of metabolic and anatomical data for comprehensive diagnostic evaluation.
This device is intended for use in clinical radiology settings and is supplied as a reusable medical imaging system. It is classified as a Class II device under FDA regulations and holds a Traditional 510(k) clearance with the Radiology (RA) Advisory Committee. The Biograph One is not single-use and requires proper maintenance and calibration in accordance with manufacturer guidelines to ensure accurate imaging performance.
From the manufacturer
BIOGRAPH One supports one patient-centric pathway to personalized care. By seamlessly integrating PET and MR into one comprehensive exam, it supports clinicians from diagnosis and staging, through a personalized therapy decision to regular therapy assessments to excel precision and support one streamlined approach.
BIOGRAPH One reduces patient slot times by more than 50 % to under 30 minutes5for standard whole-body exams, including dedicated brain protocols. With up to 5x faster positioning5and 2x faster acquisition5- BIOGRAPH One establishes PET/MR as a standard clinical modality, aligning patient slot times with typical clinical workflows.
Other devices from Siemens Healthineers AG
Questions
AI-generated answers, 18 Sep 2026
What types of imaging modalities does the Biograph One combine, and why is this combination beneficial for clinical radiology?
The Biograph One combines positron emission tomography (PET) with magnetic resonance imaging (MRI) into a single hybrid system. This integration allows simultaneous acquisition of metabolic activity data (from PET) and detailed anatomical information (from MRI), providing a comprehensive diagnostic evaluation that enhances accuracy in radiology. Clinicians can correlate functional and structural data without the need for separate scans, improving workflow efficiency and diagnostic confidence.
Is the Biograph One designed for single-use or reusable applications, and what maintenance is required to ensure optimal performance?
The Biograph One is a reusable medical imaging system, not intended for single-use. To maintain accurate imaging performance, it requires regular maintenance and calibration as specified by the manufacturer. Proper upkeep is essential for ensuring consistent PET/MR functionality and compliance with clinical standards.
How is the Biograph One classified under FDA regulations, and which advisory committee was involved in its review?
The Biograph One is classified as a Class II device under FDA regulations and holds a Traditional 510(k) clearance. Its review was conducted by the Radiology (RA) Advisory Committee, which evaluates submissions for tomographic imaging devices in the radiology specialty.
What clinical setting is the Biograph One intended for, and what are the key features that make it suitable for that environment?
The Biograph One is designed for clinical radiology settings, where hybrid imaging capabilities are valuable. Its integration of PET and MRI into a single system enables comprehensive diagnostic evaluations by providing both metabolic and anatomical data simultaneously. This reduces scan time, minimizes patient exposure to contrast agents, and improves diagnostic accuracy—key advantages in radiology departments.