# K230800: Xvision-525, Horizon, HI-300, HI-500, Saturn-F PF32, Saturn-F PF40, Saturn-F PF50

- Pathway: 510(k) (Traditional)
- Applicant: Gemss Healthcare CO., LTD.
- Decided: Nov 2, 2023 after 224 days
- Product code: KPR (System, X-Ray, Stationary)
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K981556 (1998). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192364: GXR-Series Diagnostic X-Ray System, DRGEM Corporation (2019) Summary page 4.

## Indications for use
The XVISION-525 diagnostic X-ray system is a stationary X-ray imaging system, for the purpose of acquiring X-ray images of the desired parts of a patient’s anatomy. This device is not intended for mammography or bone density applications.

Source page: https://510kreport.com/device/K230800
Methodology: https://510kreport.com/methodology