# K091628: Optimax, Compact 2, Optimax 2010, Ecomax

- Pathway: 510(k) (Traditional)
- Applicant: Protec GmbH & Co. KG
- Decided: Aug 21, 2009 after 78 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.
No later device cites it as a predicate yet.
0 of 2 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.

## Indications for use
OPTIMAX, COMPACT2, OPTIMAX 2010, ECOMAX are all Automatic X-Ray Film Processors (Regulation No. 892.1900). The devices mentioned above are 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/K091628
Methodology: https://510kreport.com/methodology