510(k) · Cleared
ClearedTrimax Radiographic Cassette
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Imation Corp. · IXA Cassette, Radiographic Film
Cleared on Mar 23, 1998 after a 27-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.
- Decided
- Mar 23, 1998
- Review
- 27 days
- Class
- Class II
- Product code
- IXA
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK980722 Trimax Radiographic CassetteImation Corp. · 1998
- Descendant · cites it directly · 0 of its ownK081557 Portable Supine Patient Support and Cassette HolderJddb Manufacturing, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK012373 Liferay WL Cassette, Liferay KW CassetteFerrania S.P.A. · 2001
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K980722 | Trimax Radiographic Cassette | Imation Corp. | 1998 | — |
| +1 | K081557 | Portable Supine Patient Support and Cassette Holder | Jddb Manufacturing, Inc. | 2008 | — |
| +1 | K012373 | Liferay WL Cassette, Liferay KW Cassette | Ferrania S.P.A. | 2001 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2008 | 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? (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 |
|---|---|---|---|
| * | — | DuPont/Sterling Intensifying Screens and Cassettes Named without a submission number |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K081557 (Jddb Manufacturing, Inc., 2008) has gone furthest, with 0 descendants of its own.
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?
Imation Trimax Cassettes are intended 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 light-proof enclosure for direct exposure of radiographic film.
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/K980722 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980722: Trimax Radiographic Cassette.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980722
Report an extraction error
Are you the manufacturer?
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