# K024188: UP-DF500 Filmstation Digital Film Imager

- Pathway: 510(k) (Traditional)
- Applicant: Sony Medical Systems
- Decided: Feb 4, 2003 after 47 days
- Product code: LMC (Camera, Multi Format, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K002146 (2000). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010275: Drystar 4500 Printer, Model 4500, Agfa Medical Imaging (2001)
- K021054: Codonics Horizon CI Medical Multimedia Dry Imager; Codonics Horizon GS Medical Multimedia Grey Scale Dry Imager, Codonics, Inc. (2002)
- K962967: Fuji Medical Dry Imager FM-DP 2636, Fujifilm Medical System U.S.A., Inc. (1996) Summary page 1.

## Cited in the summary but kept off the family tree
- K020146: Serralnyl, Serral, S.A. DE C.V. (2002). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K083522: Sony UP-DF750 Digital Film Imager (2009), 0 descendants of its own

## Indications for use
The Sony UP-DFSOO FilmStationTMDigital Film Imager is a thermal printer intended for use in printing high-resolution diagnostic images from CT, MRI or other compatible medical imaging systems. The Sony UP-DFSOO is intended for use by medical radiologists or other appropriately trained medical personnel.

Source page: https://510kreport.com/device/K024188
Methodology: https://510kreport.com/methodology