510(k) · Cleared
ClearedImation Trimatic Digital System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Imation Corp. · LMA Digitizer, Image, Radiological
Cleared on Jan 25, 1999 as substantially equivalent to K982785 (Array Corp., 1998) after a 59-day review. Its family tree reaches back 2 generations to 1993.
- Decided
- Jan 25, 1999
- Review
- 59 days
- Class
- Class II
- Product code
- LMA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K933129 (1993). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K933129 | Lumiscan 50 | Lumisys, Inc. | 1993 | — |
| −1 | K982785 | Film Digitizer Model 2905 | Array Corp. | 1998 | — |
| 0 (this device) | K984252 | Imation Trimatic Digital System | Imation Corp. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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 LMA? 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 |
|---|---|---|---|
| * | K982785 | Film Digitizer Model 2905Summary page 1…e: The Imation™ Trimatic Digital System is comprised of cleared or exempt devices with the exception of the digitizer, which is identical to the digitizer in clearance (K982785) except for minor film feeding hardware and communication software. Description and Intended Use of Device: The Imation™ Trimat… | 1998 |
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?
- The line of descent spans 6 years and passes through 3 companies; a new generation was cleared every 5.0 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All LMA devicesLMA Digitizer, Image, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LMA
3in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · LMA
80in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LMA
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LMA
1in 2013
MAUDE reports naming product code LMA, 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 | 3 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 3 | 80 | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 1 | 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 Imation™ Trimatic™ Digital System is intended for use an automated system to convert radiographic films into a DICOM format image for use in a hospital or other clinical Image Management System(IMS). The digitizer has the resolution capable of faithfully digitizing standard and mammographic x-ray films.
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/K984252 · printed Nov 4, 2026
Cite this page
510(k) Report. “K984252: Imation Trimatic Digital System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K984252
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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