# K993861: Fuji Computed Radiography Dual Side Reading, Both Side Reading, FCR 5501D Dual Side Reader

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Medical System U.S.A., Inc.
- Decided: Feb 10, 2000 after 87 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K944046 (1995). 2 ancestors in all.
82 later devices descend from it; 3 cite it directly.
0 of 85 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944046: Fuji Computed Radiography Systems, Fujifilm Medical System U.S.A., Inc. (1995) Summary page 1.
- K951373: Fuji Computed Radiography System FCR9000HQ, FCR9501HQ, Fujifilm Medical System U.S.A., Inc. (1995) Summary page 1.

## Most influential descendants
- K024147: Paxscan 4030 Medical Digital Imaging System (2003), 78 descendants of its own
- 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

## Recalls of this device
- Sep 30, 2004 · Not classified · Z-0055-05: Genital Protector Shield used with Fuji Computed Radiography (FCR) system models 5501D and XU/D1. Model: GP344 may detach from the mounting block and fall during use.

## Indications for use
The indications for use of the FCR 5501D is the same as the predicate device: the identification, capture, digitization, and processing of diagnostic x-ray images, and associating patient and exam identification with the images.

Source page: https://510kreport.com/device/K993861
Methodology: https://510kreport.com/methodology