# K110210: Saturn 8000-GS

- Pathway: 510(k) (Traditional)
- Applicant: New Medical Co., Ltd.
- Decided: Apr 20, 2011 after 85 days
- Product code: MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager))
- 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: 1 generation back to K063710 (2007). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063710: Saturn 9000, New Medical Co., Ltd. (2007) Summary page 2.
- (no number) New Medical Saturn 9000 System: named in the summary without a submission number

## Indications for use
The Digital X-ray Capture Device Saturn 8000-GS Systems is indicated for use in general radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures (excluding fluoroscopic, angiographic, and mammographic applications).

Source page: https://510kreport.com/device/K110210
Methodology: https://510kreport.com/methodology