# K992818: Optimax/ Compact 2

- Pathway: 510(k) (Traditional)
- Applicant: Protec GmbH & Co. KG
- Decided: Sep 1, 1999 after 12 days
- Product code: IXW (Processor, Radiographic-Film, Automatic)
- Device class: 2
- Regulation: 21 CFR 892.1900
- 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 K954345 (1995). 1 ancestor in all.
2 later devices descend from it; 2 cite 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)
- K954345: Doosan DSP 3800 Automatic X-Ray Film Processor, Doosan Corp. (1995) Summary page 1.

## Most influential descendants
- K023801: Film Processor, Model Life Ray Pro 1000 (2003), 0 descendants of its own
- K023825: Film Processor, Model Life Ray Pro 2500 (2003), 0 descendants of its own

## Indications for use
The Automatic X-Ray Film Processor is intended to be used to process films exposed for medical purposes. The automatic and continuous process contains developing, fixing, washing and drying of films. This may be used in all general radiographic, diagnostic imaging procedures. Typical users of this system are trained medical professionals, including but not limited to physicians, nurses, and lab technicians.

Source page: https://510kreport.com/device/K992818
Methodology: https://510kreport.com/methodology