# K210418: HYPER Focus

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai United Imaging Healthcare Co., Ltd.
- Decided: Apr 9, 2021 after 57 days
- Product code: KPS (System, Tomography, Computed, Emission)
- 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: 7 generations back to K010641 (2001). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113408: Q. Freeze (Motion VUE2), Ge Medical Systems, LLC (2012) Summary page 6.

## Indications for use
HYPER Focus can be used to correct respiratory motion in PET images. Relative to non-corrected images, HYPER Focus can reduce respiratory motion effects and thus improve the measurement accuracy of SUV and lesion volume.

Source page: https://510kreport.com/device/K210418
Methodology: https://510kreport.com/methodology