# K032635: Drystar 5300 Medical Image Printer, Model 5300

- Pathway: 510(k) (Special)
- Applicant: Agfa Corp.
- Decided: Sep 24, 2003 after 29 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: 2 generations back to K010275 (2001). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943602: DI-2000, Miles Inc., Agfa Division (1995) Summary page 1.
- K023287: Drystar 5500, Agfa Corp. (2002)

## Most influential descendants
- K061302: Digital Printer P6000D Series, Model P6000DU (2006), 0 descendants of its own

## Indications for use
The Drystar 5300 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/K032635
Methodology: https://510kreport.com/methodology