# K032210: Alara Crystalview Computed Radiography System

- Pathway: 510(k) (Traditional)
- Applicant: Alara, Inc.
- Decided: Oct 2, 2003 after 73 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: 2 generations back to K904519 (1991). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001499: Phormax Eagle Scanner System, Phormax Corp. (2000)
- K974597: Adc Compact (Agfa Diagnostic Center), Bayer Corp., Agfa Div. (1998) Summary page 1.

## Most influential descendants
- K061538: Alara Crystalview Computed Radiography System, Model R200 (2006), 1 descendant of its own
- K062390: Crystalview R200 (2006), 0 descendants of its own

## Indications for use
CRystalView is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic fildscreen systems in all general-purpose diagnostic procedures.

Source page: https://510kreport.com/device/K032210
Methodology: https://510kreport.com/methodology