# K072984: Saturn 9000-550

- Pathway: 510(k) (Special)
- Applicant: New Medical Co., Ltd.
- Decided: Nov 14, 2007 after 22 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 1.
- (no number) Saturn 9000: named in the summary without a submission number

## Indications for use
The Saturn 9000-550 system generates digital X-ray images that can be used for general X-ray system not for Mammography. The Saturn 9000-550 system can interface to traditional X-ray generator and get digital X-ray image. The Saturn 9000-550 is infended to be used in same clinical application as traditional film-screen based general radiography system.

Source page: https://510kreport.com/device/K072984
Methodology: https://510kreport.com/methodology