510(k) · Cleared
ClearedImation SE-204 Laser Imager
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Imation Enterprises Corp. · LMC Camera, Multi Format, Radiological
Cleared on Nov 19, 1997 as substantially equivalent to K936152 (3M Information,Imaging and Electronic Sector, 1994) and 1 other predicate after a 112-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Nov 19, 1997
- Review
- 112 days
- Class
- Class II
- Product code
- LMC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K936152 (1994). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK936152 3M 1152 Laser Imager3M Information,Imaging and Electronic Sector · 1994
- This deviceK972822 Imation SE-204 Laser ImagerImation Enterprises Corp. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K936152 | 3M 1152 Laser Imager | 3M Information,Imaging and Electronic Sector | 1994 | — |
| 0 (this device) | K972822 | Imation SE-204 Laser Imager | Imation Enterprises Corp. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 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 LMC? 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 |
|---|---|---|---|
| * | K936152 | 3M 1152 Laser ImagerSummary page 1…4 Laser Imager Common name: Laser Printer Classification name: ~ Magnetic Resonance Diagnostic Device 21 CFR 892.1000 Predicate devices: 3M(Imation™) 8300 Laser Imager(K936152) Agfa LR 5200 Laser Film Recorder(K964414) Description And Intended Use of Device: The Imation™ SE-204 laser imager is intended… | 1994 |
| * | K964414 | LR 5200 Laser Film RecorderSummary page 1…Classification name: ~ Magnetic Resonance Diagnostic Device 21 CFR 892.1000 Predicate devices: 3M(Imation™) 8300 Laser Imager(K936152) Agfa LR 5200 Laser Film Recorder(K964414) Description And Intended Use of Device: The Imation™ SE-204 laser imager is intended use as a high resolution hard copy device… | 1997 |
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?
- 1 of the 2 ancestors has a recall of any class.
How does its category compare?
All LMC devicesLMC Camera, Multi Format, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LMC
2in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · LMC
80in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LMC
1in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LMC
2in 2018
MAUDE reports naming product code LMC, 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 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 1 | 0 |
| 2009 | 3 | 80 | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 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 Imation™ SE-204 laser imager is intended use as a high resolution hard copy device for output from digital imaging source modalities for use in medical imaging diagnosis and referral. Electronic image information signals are managed in the SE-204 and transformed optically to expose Imation imaging media. The system is intended for use with a variety of digital modalities, including, but not limited to Digital Radiography and full view digital mammography for diagnostic use by medical radiologists and communications to referring physicians and their patients.
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/K972822 · printed Nov 3, 2026
Cite this page
510(k) Report. “K972822: Imation SE-204 Laser Imager.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K972822
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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