# K012941: Drystar, Model 4500M

- Pathway: 510(k) (Traditional)
- Applicant: Agfa Corp.
- Decided: Nov 29, 2001 after 90 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 K002146 (2000). 2 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 11 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)
- K002146: Kodak Dryview 8610 Laser Imager / for Mammography, Eastman Kodak Company (2000) Summary page 1.

## Most influential descendants
- K021054: Codonics Horizon CI Medical Multimedia Dry Imager; Codonics Horizon GS Medical Multimedia Grey Scale Dry Imager (2002), 6 descendants of its own
- K060440: Codonics Horizon XL Digital Direct Long Film Imager; Codonics Horizon XL-X Long Film Imager (2006), 1 descendant of its own
- K042232: NP-2600 Series Hardcopy Printers (2004), 1 descendant of its own
- K024188: UP-DF500 Filmstation Digital Film Imager (2003), 1 descendant of its own
- K111566: Dryview Chroma Imaging System (2011), 0 descendants of its own

## Indications for use
The Drystar 4500M 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, including digital mammography.

Source page: https://510kreport.com/device/K012941
Methodology: https://510kreport.com/methodology