510(k) · Cleared
Recalled · 2005Agfa Mamoray Mammographic Cassette, Agfa Metal-Bodied Cawo Cassette, Agfa Curix and Lightweight Cassette
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Agfa Corp. · IXA Cassette, Radiographic Film
Cleared on Sep 26, 2002 as substantially equivalent to K790273 (Agfa-Gevaert, Inc., 1979) and 1 other predicate after a 15-day review. Its family tree reaches back 1 generation to 1979. It has been recalled once.
- Decided
- Sep 26, 2002
- Review
- 15 days
- Class
- Class II
- Product code
- IXA
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K790273 (1979). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK790273 Mammography System and CassetteAgfa-Gevaert, Inc. · 1979
- This deviceK023020 Agfa Mamoray Mammographic Cassette, Agfa Metal-Bodied Cawo Cassette…Agfa Corp. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K790273 | Mammography System and Cassette | Agfa-Gevaert, Inc. | 1979 | — |
| 0 (this device) | K023020 | Agfa Mamoray Mammographic Cassette, Agfa Metal-Bodied Cawo Cassette, Agfa… | Agfa Corp. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
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 IXA? 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? (2)
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 |
|---|---|---|---|
| * | K790273 | Mammography System and CassetteSummary page 1…Mamoray Mammography Cassettes are substantially equivalent to the Agfa Mammography Cassettes, which were cleared for marketing by FDA on March 21, 1979 as K790273. The Agfa Metal-Bodied CAWO Cassette is substantially equivalent to the Kodak X-Omat Cassette, which was cleared fo… | 1979 |
| * | K890750 | Kodak X-Omatic RA CassetteSummary page 1…3. The Agfa Metal-Bodied CAWO Cassette is substantially equivalent to the Kodak X-Omat Cassette, which was cleared for marketing by FDA on March 1, 1989 as K890750. The Plastic Curix and Lightweight Cassettes are also substantially equivalent to the Kodak X-Omat Cassette. C.… | 1989 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 26, 2005 | Not classified | Z-1404-05 | Other | Users of these cassettes may detect poor film to screen contact and unsatisfactory sharpness of radiographic images. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
How does its category compare?
All IXA devicesIXA Cassette, Radiographic Film: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IXA
1in 2008
2026 to Oct 25, outlined.
Median 510(k) review, days · IXA
Too few IXA 510(k)s in any year since 2007 to give a median.
Recalls per year · IXA
No recall names IXA since 2007.
Adverse event reports per year · IXA
1in 2014
MAUDE reports naming product code IXA, 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 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 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?
The Agfa Film Cassettes are indicated for use during diagnostic x-ray procedures to hold a radiographic film in close contact with an x-ray intensifying screen and to provide a lightproof enclosure for direct exposure of radiographic film.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023020 · printed Nov 4, 2026
Cite this page
510(k) Report. “K023020: Agfa Mamoray Mammographic Cassette, Agfa Metal-Bodied Cawo Cassette, Agfa Curix and Lightweight Cassette.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K023020
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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