# K042023: Fuji Computed Radiography (FCR) Clearview CS Image Reader

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Medical System U.S.A., Inc.
- Decided: Aug 25, 2004 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
No predicates in its family tree.
58 later devices descend from it; 2 cite it directly.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) FCR 9000HQ Image Reader: named in the summary without a submission number
- (no number) FCR 5501D Image Reader: named in the summary without a submission number
- (no number) FCR 9000 Image Reader: named in the summary without a submission number

## Most influential descendants
- K100762: Flat Panel Detector, Model FDR D-Evo (2010), 55 descendants of its own
- K103596: Wireless/Wired FDR D-Evo Flat Panel Detector (2011), 54 descendants of its own
- K111548: Wireless/Wired FDR D-Evo Flat Pancel Detector System Model DR-ID600 W/DR-ID611SE (2011), 52 descendants of its own
- K132509: FDR D-Evo Flat Panel Detector System (2013), 50 descendants of its own
- K141765: FDR D-Evo Flat Panel Detector System (2014), 32 descendants of its own

## Indications for use
The indications for use of the Fuji Computed Radiography (FCR) ClearView CS image Reader with Image Plate (IP) reading is the identification, capture, digitization, and processing of diagnostic x-ray images of the human body, and associating patient and exam identification with the images.

Source page: https://510kreport.com/device/K042023
Methodology: https://510kreport.com/methodology