# K083503: DRAD30003/Radrex-I

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba America Medical Systems, In.C
- Decided: Feb 13, 2009 after 79 days
- Product code: KPR (System, X-Ray, Stationary)
- 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: 4 generations back to K931071 (1994). 6 ancestors in all.
1 later device descends 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)
- K082494: DRAD3000E/Radrex-I, Toshiba America Medical Systems, In.C (2008) Summary page 1.
- K982795: Philips Bucky Vision, Philips Medical Systems, Inc. (1998) Summary page 1.

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

## Recalls of this device
- Dec 29, 2011 · Not classified · Z-0941-2012: It has been found that some of the starter cables used for x-ray tube high speed rotation are not sufficiently durable.

## Indications for use
This system is intended for use in conjunction with the ceiling-suspended tube support, high voltage generator, and bucky stand (fixed detector only)-or bucky table incorporating a fixed or detachable (portable) flat panel detector for radiography of the head, chest; abdomen, spine, neck and limbs. This system is used for image acquisition, image display and transmission/output or images to external devices. Excluded indications include mammegraphy, fluoroscopy and anglography studies.

Source page: https://510kreport.com/device/K083503
Methodology: https://510kreport.com/methodology