# K230856: BrainSpec Core™ Software

- Pathway: 510(k) (Traditional)
- Applicant: Brainspec, Inc.
- Decided: Nov 14, 2023 after 230 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K971684 (1997). 22 ancestors in all.
No later device cites it as a predicate yet.
2 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120315: Syngo.MR Spectro Engine, Syngo.MR Spectro SVS, Syngo.MR Spectro Csi, Syngo.MR Spectro Extension, Siemens Medical Solutions USA, Inc. (2012) Summary page 6.

## Indications for use
BrainSpec Core™ software is a post-processing application to analyze and evaluate MR (magnetic resonance) spectroscopy data. It provides evaluation of MR Single Voxel Spectroscopy (SVS) data and MR Chemical Shift Imaging (CSI) data to support the diagnostic process. BrainSpec Core™ software includes the possibility of an integrated reading of MR images and spectroscopy data for spectroscopy exams and focuses on ease-of-use by reducing complexity. A fit algorithm reduces the need for manual data processing and offers the user reproducible evaluation results. When interpreted by a trained physician, these results provide information that may assist in diagnosis. The post-processing fits and displays spectra and provides intuitive representations of the metabolic profile. The calculation and display of pre-defined results such as spectra, spectral maps, and metabolite images is provided. Interactive reading of spectroscopy exams is supported by side-by-side display of MR images and spectroscopy results, and synchronized display.

Source page: https://510kreport.com/device/K230856
Methodology: https://510kreport.com/methodology