# K122842: Radrex-I, SW V4.00 Model Drad-3000E

- Pathway: 510(k) (Special)
- Applicant: Toshiba America Medical Systems, In.C
- Decided: Oct 9, 2012 after 22 days
- Product code: MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager))
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K931071 (1994). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082494: DRAD3000E/Radrex-I, Toshiba America Medical Systems, In.C (2008) Summary page 1.
- K083503: DRAD30003/Radrex-I, Toshiba America Medical Systems, In.C (2009) Summary page 1.

## Recalls of this device
- Oct 16, 2018 · Class II · Z-1958-2019: software malfunction; It was found when a user performs radiography using the wireless flat panel detector (FPD), a message window displays on the monitor stating image transmission was not completed 
- Apr 18, 2018 · Class II · Z-2964-2018: It was found when an operator performs a radiography using the wireless flat panel detector (FPD), a message window was displayed on the monitor stating image transmission was not completed and there 
- Mar 23, 2017 · Class II · Z-3111-2017: It was discovered during a procedure that when the operator made an exposure on the wireless x-ray detector and the image data was sent to the digital radiography system, and error message was display

## Indications for use
This device is indicated as a general radiography device. It is capable of providing digital images of the head, neck, spine, chest, abdomen, and limbs by converting x-rays to digital images. Excluded indications include mammography, fluoroscopy and angiography studies.

Source page: https://510kreport.com/device/K122842
Methodology: https://510kreport.com/methodology