# K052251: Drystar Model 5500

- Pathway: 510(k) (Traditional)
- Applicant: Agfa Corporation
- Decided: Aug 31, 2005 after 13 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 K002146 (2000). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012941: Drystar, Model 4500M, Agfa Corp. (2001) Summary page 1.
- K023287: Drystar 5500, Agfa Corp. (2002) Summary page 1.

## Indications for use
The Drystar 5500M is a free standing device used to print diagnostic conventional and mammography 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/K052251
Methodology: https://510kreport.com/methodology