# K200213: Biograph mMR with syngo MR E11P-AP01 system software

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: May 11, 2020 after 104 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: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K971684 (1997). 54 ancestors in all.
1 later device descends from it; 1 cites it directly.
6 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163234: Biograph mMR with syngo MR E11P system software, Siemens Medical Solutions USA, Inc. (2017) Summary page 5.

## Most influential descendants
- K253023: BIOGRAPH One (2026), 0 descendants of its own

## Recalls of this device
- Aug 28, 2025 · Class I · Z-2654-2025: There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, l

## Indications for use
The Siemens MR-PET system combines magnetic resonance diagnostic devices (MRDD) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information, acquired simultaneously and isocentrically. The combined system maintains independent functionality of the MR and PET devices, allowing for single modality MR and / or PET imaging. These systems are intended to be utilized by appropriately trained health care professionals to aid in the detection, localization, and diagnosis of diseases and disorders. The MR is intended to produce transverse, sagittal, coronal and oblique crosssectional MR images, spectroscopic images and/or spectra, and displays the internal structure and/or function of the human body. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, approved contrast agents may be used, as described in their labeling. This system may also be used for imaging during interventional procedures when performed with MR compatible devices, such as MR safe biopsy needles. 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 combined system utilizes the MR for radiation-free attenuation correction maps for PET studies. The system provides inherent anatomical reference for the fused PET and MR images due to precisely aligned MR and PET image coordinate systems.

Source page: https://510kreport.com/device/K200213
Methodology: https://510kreport.com/methodology