# K063710: Saturn 9000

- Pathway: 510(k) (Traditional)
- Applicant: New Medical Co., Ltd.
- Decided: Jul 16, 2007 after 214 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.
73 later devices descend from it; 4 cite it directly.
0 of 74 devices 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) StingRay: named in the summary without a submission number

## Most influential descendants
- K080064: Flaatz 750 (2008), 69 descendants of its own
- K113812: ATAL-8 (2012), 41 descendants of its own
- K123644: Vizion + DR (2013), 33 descendants of its own
- K152279: ViZion DR + Wireless (2015), 27 descendants of its own
- K161730: Wireless Digital Flat Panel Detector (2016), 24 descendants of its own

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

Source page: https://510kreport.com/device/K063710
Methodology: https://510kreport.com/methodology