# K050925: Digital Radiography System Radspeed Safire

- Pathway: 510(k) (Abbreviated)
- Applicant: Shimadzu Corp.
- Decided: Jun 1, 2005 after 49 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.
15 later devices descend from it; 3 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K052500: DAR-8000F (2005), 8 descendants of its own
- K131075: X-Ray TV System Sonial Vision G4 (2014), 6 descendants of its own
- K142341: X-Ray TV System Sonialvision G4 (2015), 5 descendants of its own
- K190373: SonialVision G4 (2019), 4 descendants of its own
- K080859: DRF 4343 (2008), 2 descendants of its own

## Indications for use
The digital radiography unit DAR-7000 is a radiographic system for a general acquisition using the flat panel sensor as X-ray detector. X-ray detector equipped with FPD (Flat Panel Detector) allows user to acquire a high-quality image. This system is designed to display digitizing the image, and to register or manipulate that image data. This unit is not used for mammography.

Source page: https://510kreport.com/device/K050925
Methodology: https://510kreport.com/methodology