# K131075: X-Ray TV System Sonial Vision G4

- Pathway: 510(k) (Abbreviated)
- Applicant: Shimadzu Corp.
- Decided: Mar 28, 2014 after 345 days
- Product code: JAA (System, X-Ray, Fluoroscopic, Image-Intensified)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K050925 (2005). 2 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052500: DAR-8000F, Shimadzu Medical Systems (2005) Summary page 1.

## Most influential descendants
- K142341: X-Ray TV System Sonialvision G4 (2015), 5 descendants of its own
- K190373: SonialVision G4 (2019), 4 descendants of its own
- K212212: Multitom Rax with True2scale Body Scan Option (2022), 1 descendant of its own
- K221281: Multitom Rax (2022), 0 descendants of its own
- K212145: DR 800 with DSA, DR 800 (2021), 0 descendants of its own

## Indications for use
The SONIALVISION G4 is intended to be used for the fluoroscopy/radiography diagnosis in hospital. The equipment must only be operated by qualified personnel, such as radiography technicians or those with equivalent qualifications. The system is used for total patient population. This system is NOT intended to be used for Mammography screening. This system is NOT intended to be used for interventional procedure, This system is used for radiographic, fluoroscopic, angiographic and pediatric examinations. Stored images in this system can be used for re-monitoring, image processing, storing to optical media (CD/DVD), and sending to DICOM server.

Source page: https://510kreport.com/device/K131075
Methodology: https://510kreport.com/methodology