# K191877: FLUOROspeed

- Pathway: 510(k) (Special)
- Applicant: Shimadzu Corporation
- Decided: Aug 5, 2019 after 21 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: 8 generations back to K862120 (1986). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190373: SonialVision G4, Shimadzu Corporation (2019) Summary page 4.

## Recalls of this device
- Sep 6, 2024 · Class II · Z-0317-2025: 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-0867-2022: 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.

Source page: https://510kreport.com/device/K191877
Methodology: https://510kreport.com/methodology