# K021099: Rex, Version 1.0

- Pathway: 510(k) (Traditional)
- Applicant: Pointdx, Inc.
- Decided: Jun 27, 2002 after 84 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K954678 (1996). 4 ancestors in all.
77 later devices descend from it; 1 cites it directly.
0 of 82 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012290: Rapidia, 3D Med Co., Ltd. (2001)

## Most influential descendants
- K030457: Rex, Version 3.0 (2003), 76 descendants of its own
- K033955: RTIST (2004), 75 descendants of its own
- K101228: Mirada XD (2010), 70 descendants of its own
- K102687: Mirada RT (2010), 37 descendants of its own
- K130393: Mirada RTX (2013), 36 descendants of its own

## Indications for use
REXTM1.0 is a software package intended for viewing and manipulating DICOM-compliant medical images acquired from CT scanners. REXTM1.O can be used for real-time image viewing, image manipulation, 3D volume rendering, virtual endoscopy, and issuance of reports.

Source page: https://510kreport.com/device/K021099
Methodology: https://510kreport.com/methodology