# K100400: Prestodr Portable

- Pathway: 510(k) (Special)
- Applicant: Cmt Medical Technologies, Ltd.
- Decided: Apr 22, 2010 after 65 days
- Product code: IZL (System, X-Ray, Mobile)
- Device class: 2
- Regulation: 21 CFR 892.1720
- 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). 6 ancestors in all.
3 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)
- K003438: Smart Rad, Cmt Medical Technologies, Ltd. (2001) Summary page 1.
- K090625: Wireless Portable Detector FD-W17, Philips Medical Systems North America Co. (2009) Summary page 1.

## Most influential descendants
- K110849: Prestodr 4143 (2011), 1 descendant of its own
- K162224: ArtPix Mobile EZ2GO (2016), 0 descendants of its own
- K131314: Ddrcruze (Digital Mobile Diagnostic X-Ray System) (2013), 0 descendants of its own

## Indications for use
The PrestoDR Portable ™, is intended for use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. PrestoDR Portable ™ allows imaging of the skull, chest, shoulders, spine, abdomen, and extremities.

Source page: https://510kreport.com/device/K100400
Methodology: https://510kreport.com/methodology