# K253963: Cubresa BrainPET

- Pathway: 510(k) (Traditional)
- Applicant: Cubresa, Inc.
- Decided: Jul 17, 2026 after 218 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: none
- 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.
No later device cites it as a predicate yet.
5 of 55 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.

## Indications for use
The Cubresa BrainPET is a Positron Emission Tomography (PET) scanner, containing MR transmit and Receive head coils, and is intended for use with the Siemens Biograph mMR with syngo software to provide high resolution physiologic and anatomic information via PET and MR modalities acquired simultaneously and isocentrically. The Cubresa BrainPET maintains independent functionality of the MR and PET devices, allowing for single-modality MR or simultaneous PET/MR imaging. The Cubresa BrainPET system is intended to be utilized by appropriately trained health care professionals to aid in the detection, localization, and diagnosis of diseases and disorders of the brain. The Cubresa BrainPET MR Coil is intended to produce transverse, sagittal, coronal, and oblique cross-sectional MR images, spectroscopic images and/or spectra, and displays the internal structure and/or function of the human brain. The Cubresa BrainPET images and measures the distribution of PET radiopharmaceuticals in the human head to aid in the evaluation of various metabolic (molecular) and physiologic functions within the human brain for evaluation of diseases and disorders such as, but not limited to, neurological diseases and disorders. The Cubresa BrainPET utilizes the MR System for attenuation correction maps for PET studies. The system provides inherent anatomical reference for the PET and MR images due to precisely aligned MR and PET image coordinate systems.

Source page: https://510kreport.com/device/K253963
Methodology: https://510kreport.com/methodology