# K024147: Paxscan 4030 Medical Digital Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Varian Medical Systems, Inc.
- Decided: Feb 12, 2003 after 58 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: 4 generations back to K803130 (1981). 16 ancestors in all.
78 later devices descend from it; 6 cite it directly.
0 of 95 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982795: Philips Bucky Vision, Philips Medical Systems, Inc. (1998) Summary page 1.
- K981556: Canon X-Ray Digital Camera Cxdi-11, Canon USA, Inc. (1998) Summary page 1.
- K993861: Fuji Computed Radiography Dual Side Reading, Both Side Reading, FCR 5501D Dual Side Reader, Fujifilm Medical System U.S.A., Inc. (2000) Summary page 1.
- K992794: Stingray DR, Model 1, Infimed, Inc. (1999) Summary page 1.

## Most influential descendants
- K092669: DX-D Imaging Package (2009), 34 descendants of its own
- K120020: Vivix-S (2012), 30 descendants of its own
- K122865: Vivix-S Wireless (2013), 28 descendants of its own
- K122736: DX-D Imaging Package (2013), 25 descendants of its own
- K140771: Philips Eleva Workspot (2014), 15 descendants of its own

## Indications for use
The PaxScan 4030 Medical Digital Imaging System is intended for use in generating radiographic images of human anatomy. It is intended to replace film/screen or computed radiography in extremity and general-purpose procedures appropriate to the input field of view. This device is intended for use by qualified medical personnel trained in radiology

Source page: https://510kreport.com/device/K024147
Methodology: https://510kreport.com/methodology