510(k) · Cleared
Cleared3M Trimatic Modular Advanced Processing System and 3M Aps Automatic Film Processor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Imation Corp. · IXW Processor, Radiographic-Film, Automatic
Cleared on Aug 21, 1996 as substantially equivalent to K880565 (3M Company, 1988) and 1 other predicate after a 37-day review. Its family tree reaches back 1 generation to 1988.
- Decided
- Aug 21, 1996
- Review
- 37 days
- Class
- Class II
- Product code
- IXW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K880565 (1988). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK880565 3M Trimatic M Modular System and Accessories3M Company · 1988
- This deviceK962750 3M Trimatic Modular Advanced Processing System and 3M Aps Automatic…Imation Corp. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K880565 | 3M Trimatic M Modular System and Accessories | 3M Company | 1988 | — |
| 0 (this device) | K962750 | 3M Trimatic Modular Advanced Processing System and 3M Aps Automatic Film… | Imation Corp. | 1996 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 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 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? (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 |
|---|---|---|---|
| * | K880565 | 3M Trimatic M Modular System and Accessories | 1988 |
| * | K880563 | 3M XP515 X-Ray Film ProcessorSummary page 1…processor - 21 CFR 892.1900 - Class II Predicate Device: 3M Trimatic™ M Plus Daylight System - (510(k) K88056S5, 21 March 1988) 3M XP 515 X-Ray Film Processor (510(k) K880563, 21 March 1988). Description and Intended Use of Device: The 3M Trimatic™ Modular Advanced Processing System is an automatic, mo… | 1988 |
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?
- None of the 2 ancestors has a 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?
The 3M Trimatic™ Modular Advanced Processing System is an automatic, modular system for unloading exposed x-ray film from x-ray film cassettes, processing the film, and reloading the empty x-ray film cassette with fresh x-ray film of the same size and type. The 3M Trimatic™ Modular APS will accommodate from four to seven different film types / sizes in film modules. This system is used for handling and processing of x-ray films from all general radiographic, diagnostic procedures which employ conventional x-ray film / screen technology.
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/K962750 · printed Nov 5, 2026
Cite this page
510(k) Report. “K962750: 3M Trimatic Modular Advanced Processing System and 3M Aps Automatic Film Processor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K962750
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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