# K241982: DeepFoqus (DeepFoqus-Accelerate)

- Pathway: 510(k) (Traditional)
- Applicant: Foqus Technologies, Inc.
- Decided: Apr 4, 2025 after 273 days
- Product code: QIH (Automated Radiological Image Processing Software)
- 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: 6 generations back to K922470 (1992). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210999: SwiftMR, Airs Medical, Inc. (2021) Summary page 5.

## Indications for use
DeepFoqus-Accelerate is a stand-alone software solution intended to be used for acceptance, enhancement, and transfer of brain MRI images in DICOM format. It can be used for reconstruction of non-contrast enhanced MRI images acquired with 1.5T or 3T Siemens and GE scanners using Sagittal, Axial, or Coronal T1, T2, or FLAIR sequences. DeepFoqus-Accelerate is intended to be used on adult scans only and not intended for use on mobile devices.

Source page: https://510kreport.com/device/K241982
Methodology: https://510kreport.com/methodology