# K210001: HYPER AiR

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai United Imaging Healthcare Co., Ltd.
- Decided: Apr 30, 2021 after 116 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: 16 generations back to K002715 (2000). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193241: Emission Computed Tomography System, Shanghai United Imaging Healthcare Co., Ltd. (2020) Summary page 4.

## Indications for use
HYPER AiR is an image processing function intended to be used by radiologists and nuclear medicine physicians to reduce noise and improve contrast of fluorodeoxyglucose (FDG) PET images.

Source page: https://510kreport.com/device/K210001
Methodology: https://510kreport.com/methodology