# K190373: SonialVision G4

- Pathway: 510(k) (Special)
- Applicant: Shimadzu Corporation
- Decided: Mar 15, 2019 after 24 days
- Product code: JAA (System, X-Ray, Fluoroscopic, Image-Intensified)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K862120 (1986). 12 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142341: X-Ray TV System Sonialvision G4, Shimadzu Corp. (2015) Summary page 4.

## Most influential descendants
- 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
- K191877: FLUOROspeed (2019), 0 descendants of its own

## Recalls of this device
- Sep 6, 2024 · Class II · Z-0316-2025: X-ray R/F system software with certain versions of the control board may occasionally fail to display images when switching from Fluoroscopy mode to Radiography mode, which may lead to the possibility
- Jan 10, 2022 · Class II · Z-0869-2022: It was found that the irradiated x-ray may exceed the xray radiation dose rate specified in CFR 1020.32 in some specific case of fluoroscopic mode due to inadequate adjusting criteria in installation.

## Indications for use
The equipment 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 equipment is used for total patient population. The equipment is NOT intended to be used for Mammography screening. The equipment is NOT intended to be used for interventional procedure. The equipment is used for radiographic, fluoroscopic, angiographic and pediatric examinations. Stored images in the equipment can be used for re-monitoring, image processing, storing to optical media (CD/DVD), and sending to DICOM server. The Tomosynthesis option for the SONIALVISION G4 is intended to generate tomographic images of human anatomy including chest or extremities. Tomosynthesis technique is used to produce a specific cross-sectional plane of the body by reconstruction of tomographic acquisition. The device is not intended for mammographic applications

Source page: https://510kreport.com/device/K190373
Methodology: https://510kreport.com/methodology