# K061538: Alara Crystalview Computed Radiography System, Model R200

- Pathway: 510(k) (Special)
- Applicant: Alara, Inc.
- Decided: Jun 30, 2006 after 28 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: 3 generations back to K904519 (1991). 4 ancestors in all.
1 later device descends 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)
- K032210: Alara Crystalview Computed Radiography System, Alara, Inc. (2003) Summary page 1.
- K974597: Adc Compact (Agfa Diagnostic Center), Bayer Corp., Agfa Div. (1998) Summary page 1.

## Most influential descendants
- K062390: Crystalview R200 (2006), 0 descendants of its own

## Indications for use
CRystalView R200 is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures.

Source page: https://510kreport.com/device/K061538
Methodology: https://510kreport.com/methodology