# K023287: Drystar 5500

- Pathway: 510(k) (Special)
- Applicant: Agfa Corp.
- Decided: Oct 22, 2002 after 20 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: 1 generation back to K010275 (2001). 1 ancestor in all.
5 later devices descend from it; 3 cite it directly.
0 of 7 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)

## Most influential descendants
- K072680: Drystar Axys, Model EYZ4E (2007), 1 descendant of its own
- K032635: Drystar 5300 Medical Image Printer, Model 5300 (2003), 1 descendant of its own
- K083522: Sony UP-DF750 Digital Film Imager (2009), 0 descendants of its own
- K061302: Digital Printer P6000D Series, Model P6000DU (2006), 0 descendants of its own
- K052251: Drystar Model 5500 (2005), 0 descendants of its own

## Indications for use
The Drystar 5500 is a free-standing printer used to print diagnostic images on transparent film for viewing on a standard view box. It may be used in any situation in which a hard copy of an image generated by a medical imaging device is required or desirable.

Source page: https://510kreport.com/device/K023287
Methodology: https://510kreport.com/methodology