# K062360: Bransist Safire

- Pathway: 510(k) (Abbreviated)
- Applicant: Shimadzu Corp.
- Decided: Oct 5, 2006 after 52 days
- Product code: IZI (System, X-Ray, Angiographic)
- Device class: 2
- Regulation: 21 CFR 892.1600
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K072006: DAR-9400F (2007), 0 descendants of its own

## Recalls of this device
- Apr 20, 2026 · Class II · Z-2294-2026: Electromagnetic contactors within high voltage generator may weld together, resulting in current being supplied to power supply even if power is off.
- Dec 16, 2021 · Class II · Z-0654-2022: Due to the inadequate adjusting criteria in installation, the system generator on two Digital Angiography Systems, the irradiated x-ray may exceed the x-ray radiation dose rate in fluoroscopic mode.
- Nov 18, 2020 · Class II · Z-0554-2021: The firm has identified a problem with the control software for the celling arm of the X-Ray System . This software issue could cause the ceiling arm of the device to move after the operator has relea
- Jan 14, 2019 · Class II · Z-0959-2019: Normal operation of the device is to power up the device in the morning, register the first patient, and then perform a fluoroscopy. If, however, the user powers up the device in the morning and makes

## Indications for use
This device is an angiographic X-ray system, as described in 21 CFR 892.1600. This system is intended to be used for radiologic visualization of the heart, blood vessels or lymphatic system during or after injection of a contrast medium. It is to be used in the diagnosis of the circulatory vascular system while being combined with a positioning device and other devices. This device is operated and used by physicians and X-ray Technologists.

Source page: https://510kreport.com/device/K062360
Methodology: https://510kreport.com/methodology