# K153312: Scatter Correction for Cxdi Series

- Pathway: 510(k) (Traditional)
- Applicant: Canon, Inc.
- Decided: Jun 28, 2016 after 224 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: 11 generations back to K981556 (1998). 46 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102012: Digital Radiography, Canon Inc. -Medical Equipment Group (2010) Summary page 4.
- K103591: Digital Radiography, Canon Inc. -Medical Equipment Group (2011) Summary page 4.
- K111682: Digital Radiography, Canon Inc. -Medical Equipment Group (2011) Summary page 4.
- K112309: Digital Radiography, Canon Inc. -Medical Equipment Group (2011) Summary page 4.
- K131106: Digital Radiography Cxdi-701C Wireless, Digital Radiography Cxdi-70IG Wireless, Digital Radiography Cxdi-801C Wireless,, Canon, Inc. (2013) Summary page 4.
- K133693: Digital Radiography Cxdi-401C Wireless, Canon, Inc. (2014) Summary page 4.
- K140771: Philips Eleva Workspot, Philips Medical Systems Dmc GmbH (2014) Summary page 4.

## Most influential descendants
- K190368: Enhanced Feature Software Pack CXDI Series (2019), 1 descendant of its own
- K212269: Intelligent NR (2021), 0 descendants of its own

## Indications for use
As a part of the CXDI series radiography system, the CXDI Control Software when used with a compatible CXDI detector is intended to provide digital image capture, processing, and display for conventional film/screen radiographic examinations. This device is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures including specialist areas like intensive care, trauma, and pediatric work. This device is not intended for fluoroscopic, angiographic, or mammography applications.

Source page: https://510kreport.com/device/K153312
Methodology: https://510kreport.com/methodology