# K063421: DX-SI

- Pathway: 510(k) (Traditional)
- Applicant: Agfa Corp.
- Decided: Nov 22, 2006 after 9 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 K803130 (1981). 5 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053634: Computed Radiography System with NX 1.0 Workstation, Agfa Corporation (2006) Summary page 1.
- K971452: Multix Top/Pro Radiographic X-Ray Table, Siemens Medical Solutions USA, Inc. (1997) Summary page 1.
- K010571: Adc QS/Ipd Workstation, Agfa Corp. (2001) Summary page 1.

## Most influential descendants
- K072010: Quantum Direx System (2007), 5 descendants of its own
- K080905: Quantum/ Canon Cxdi Integration System, Model QG-Dig-Cxdi (2008), 4 descendants of its own
- K193574: Q-Rad System (2020), 3 descendants of its own
- K201373: DRX-Compass (2020), 2 descendants of its own
- K223842: DRX - Compass (2023), 1 descendant of its own

## Indications for use
Agfa’s DX-Si system is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. The DX-Si can be used to perform radiographic exposures of the skeleton (including skull, spinal column and extremities) chest, abdomen and other body parts. The DS-Xi Is not indicated for use in mammography. Use with separately cleared accessories allows the DX-Si to be conveniently used in generating urological, tomographic, pediatric and dental images.

Source page: https://510kreport.com/device/K063421
Methodology: https://510kreport.com/methodology