# K080589: Saturn 9000-810

- Pathway: 510(k) (Special)
- Applicant: New Medical Co., Ltd.
- Decided: Jun 11, 2008 after 100 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Saturn 8000: named in the summary without a submission number

## Indications for use
The Saturn 9000-810 system generates digital X-ray images that can be used for general X-ray system not for Mammography. The Saturn 9000-810 system can Interface to traditional X-ray generator and get digital X-ray image. The Saturn 8000-810 is intended to be used in same clinical application as traditional film-screen based general radiography system.

Source page: https://510kreport.com/device/K080589
Methodology: https://510kreport.com/methodology