# K082494: DRAD3000E/Radrex-I

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba America Medical Systems, In.C
- Decided: Sep 12, 2008 after 14 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K931071 (1994). 5 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982795: Philips Bucky Vision, Philips Medical Systems, Inc. (1998) Summary page 1.
- K073165: Drad-3000E, Radrex-I, Toshiba America Medical Systems, In.C (2007) Summary page 1.

## Most influential descendants
- K083503: DRAD30003/Radrex-I (2009), 1 descendant of its own
- K122842: Radrex-I, SW V4.00 Model Drad-3000E (2012), 0 descendants of its own

## Indications for use
This device is Indicated as a general radiography device. 1tis 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, flucroscopy and angiography studes.

Source page: https://510kreport.com/device/K082494
Methodology: https://510kreport.com/methodology