# K052500: DAR-8000F

- Pathway: 510(k) (Abbreviated)
- Applicant: Shimadzu Medical Systems
- Decided: Oct 17, 2005 after 34 days
- Product code: IZI (System, X-Ray, Angiographic)
- Device class: 2
- Regulation: 21 CFR 892.1600
- 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: 1 generation back to K050925 (2005). 1 ancestor in all.
8 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050925: Digital Radiography System Radspeed Safire, Shimadzu Corp. (2005) Summary page 3.

## Most influential descendants
- 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
- K212212: Multitom Rax with True2scale Body Scan Option (2022), 1 descendant of its own
- K221281: Multitom Rax (2022), 0 descendants of its own

## Recalls of this device
- Jan 12, 2018 · Class II · Z-2060-2018: When selecting serial radiography with a pulse rate of 7.5fps (including selecting a preset or changing the pulse rate using a temporary edit function) it was observed the indicated "irradiation time"
- Apr 3, 2014 · Class II · Z-1569-2014: Shimadzu Corporation is recalling the Shimadzu Digital X-Ray System because they have received a report of a lost image under certain circumstances.

## Indications for use
This device is intended to be used for the radiography in the hospital with X-ray devices. This device is operated and used by the physicians and X-ray technologist. The object of this device is total patient population.

Source page: https://510kreport.com/device/K052500
Methodology: https://510kreport.com/methodology