# K072680: Drystar Axys, Model EYZ4E

- Pathway: 510(k) (Special)
- Applicant: Agfa Healthcare Corporation
- Decided: Oct 25, 2007 after 31 days
- Product code: LMC (Camera, Multi Format, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2040
- 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: 2 generations back to K010275 (2001). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

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

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

## Recalls of this device
- May 16, 2008 · Not classified · Z-2136-2008: The "Film Calibration" setting on the printers was set to the default "OFF" position instead of "ON".

## Indications for use
The Drystar AXYS 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/K072680
Methodology: https://510kreport.com/methodology