510(k) · Cleared
ClearedFuji Medical Laser Imager FL-IM D
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fujifilm Medical System U.S.A., Inc. · LMC Camera, Multi Format, Radiological
Cleared on Mar 9, 1995 after a 121-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Mar 9, 1995
- Review
- 121 days
- Class
- Class II
- Product code
- LMC
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK945475 Fuji Medical Laser Imager FL-IM DFujifilm Medical System U.S.A., Inc. · 1995
- Descendant · cites it directly · 2 of its ownK962967 Fuji Medical Dry Imager FM-DP 2636Fujifilm Medical System U.S.A., Inc. · 1996
- Descendant · 2 generations on · 1 of its ownK024188 UP-DF500 Filmstation Digital Film ImagerSony Medical Systems · 2003
- Descendant · 3 generations on · 0 of its ownK083522 Sony UP-DF750 Digital Film ImagerSony Electronics, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK972660 Raven Dry PrinterSterling Diagnostic Imaging, Inc. · 1997
Most influential descendants
Showing 4 of 4 · See all- K962967Fuji Medical Dry Imager FM-DP 2636Fujifilm Medical System U.S.A., Inc. · 1996 · cites it directly2descendants
- K024188UP-DF500 Filmstation Digital Film ImagerSony Medical Systems · 2003 · 2 generations on1descendant
- K083522Sony UP-DF750 Digital Film ImagerSony Electronics, Inc. · 2009 · 3 generations on0descendants
- K972660Raven Dry PrinterSterling Diagnostic Imaging, Inc. · 1997 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K945475 | Fuji Medical Laser Imager FL-IM D | Fujifilm Medical System U.S.A., Inc. | 1995 | — |
| +1 | K962967 | Fuji Medical Dry Imager FM-DP 2636 | Fujifilm Medical System U.S.A., Inc. | 1996 | — |
| +2 | K024188 | UP-DF500 Filmstation Digital Film Imager | Sony Medical Systems | 2003 | — |
| +3 | K083522 | Sony UP-DF750 Digital Film Imager | Sony Electronics, Inc. | 2009 | — |
| +1 | K972660 | Raven Dry Printer | Sterling Diagnostic Imaging, Inc. | 1997 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2003 | 1 | 0 |
| 2009 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
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, K962967 (Fujifilm Medical System U.S.A., Inc., 1996) has gone furthest, with 2 descendants of its own.
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 | — |
https://510kreport.com/device/K945475 · printed Nov 4, 2026
Cite this page
510(k) Report. “K945475: Fuji Medical Laser Imager FL-IM D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K945475
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026