# K073165: Drad-3000E, Radrex-I

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba America Medical Systems, In.C
- Decided: Nov 16, 2007 after 7 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K931071 (1994). 4 ancestors in all.
3 later devices descend from it; 1 cites 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.

## Most influential descendants
- K082494: DRAD3000E/Radrex-I (2008), 2 descendants of its own
- 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

## Recalls of this device
- May 22, 2009 · Not classified · Z-1177-2010: Toshiba America Medical Systems Inc (TAMS) has initiated a field correction on the DRAD-3000E; Radrex-I, Electrostatic x-ray imaging system due to a software bug that results in a loss of image.

## 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/K073165
Methodology: https://510kreport.com/methodology