510(k) · Cleared
ClearedCP 1000, Curix HT 330, Classic E.O.S., Curix HT 530, Mamoray HT 300, Mamoray Cmpact Plus, Curix Compact Plus, Curix Coms
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bayer Corp., Agfa Div. · IXW Processor, Radiographic-Film, Automatic
Cleared on Apr 30, 1998 after a 22-day review. The FDA summary names no predicate by number.
- Decided
- Apr 30, 1998
- Review
- 22 days
- Class
- Class II
- Product code
- IXW
- Recalls
- None
- Predicates
- 0
The FDA summary names no predicate by number.
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?
The FDA summary names no predicate by number.
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.
How does its category compare?
All IXW devicesIXW Processor, Radiographic-Film, Automatic: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
To process (develop) medical imaging films for viewing by physicians. This may be used in the imaging modalities of Ultrasound, X-Ray, Nuclear Medicine, Computed Tomography, Mammography, Cardiology, and Magnetic Resonance.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981280 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981280: CP 1000, Curix HT 330, Classic E.O.S., Curix HT 530, Mamoray HT 300, Mamoray Cmpact Plus, Curix Compact Plus, Curix Coms.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981280
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026