510(k) · Cleared
ClearedOptimax, Compact 2, Optimax 2010, Ecomax
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Protec GmbH & Co. KG · IXW Processor, Radiographic-Film, Automatic
Cleared on Aug 21, 2009 as substantially equivalent to K954345 (Doosan Corp., 1995) after a 78-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Aug 21, 2009
- Review
- 78 days
- Class
- Class II
- Product code
- IXW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K954345 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK954345 Doosan DSP 3800 Automatic X-Ray Film ProcessorDoosan Corp. · 1995
- This deviceK091628 Optimax, Compact 2, Optimax 2010, EcomaxProtec GmbH & Co. KG · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K954345 | Doosan DSP 3800 Automatic X-Ray Film Processor | Doosan Corp. | 1995 | — |
| 0 (this device) | K091628 | Optimax, Compact 2, Optimax 2010, Ecomax | Protec GmbH & Co. KG | 2009 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in IXW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K954345 | Doosan DSP 3800 Automatic X-Ray Film ProcessorSummary page 1…Classification name: Processor, Radiographic-Film, Automatic Predicate Device: The Predicate Device is a legally marketed, postamendments device: K954345 DOOSAN DSP 3800 Automatic X-Ray Film Processor Device Description Due to the precise roller transport system, bot… | 1995 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K954345.
How does its category compare?
All IXW devicesIXW Processor, Radiographic-Film, Automatic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · IXW
1in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · IXW
Too few IXW 510(k)s in any year since 2007 to give a median.
Recalls per year · IXW
No recall names IXW since 2007.
Adverse event reports per year · IXW
2in 2018
MAUDE reports naming product code IXW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091628 · printed Nov 5, 2026
Cite this page
510(k) Report. “K091628: Optimax, Compact 2, Optimax 2010, Ecomax.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091628
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026