510(k) · Cleared
ClearedUP-DF500 Filmstation Digital Film Imager
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sony Medical Systems · LMC Camera, Multi Format, Radiological
Cleared on Feb 4, 2003 as substantially equivalent to K010275 (Agfa Medical Imaging, 2001) and 2 other predicates after a 47-day review. Its family tree reaches back 3 generations to 2000. 1 later device descends from it.
- Decided
- Feb 4, 2003
- Review
- 47 days
- Class
- Class II
- Product code
- LMC
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K002146 (2000). 7 ancestors in all, the oldest K945475 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK002146 Kodak Dryview 8610 Laser Imager / for MammographyEastman Kodak Company · 2000
- 2 generations backK012941 Drystar, Model 4500MAgfa Corp. · 2001
- 1 generation backK021054 Codonics Horizon CI Medical Multimedia Dry Imager; Codonics Horizon…Codonics, Inc. · 2002
- This deviceK024188 UP-DF500 Filmstation Digital Film ImagerSony Medical Systems · 2003
- Descendant · cites it directly · 0 of its ownK083522 Sony UP-DF750 Digital Film ImagerSony Electronics, Inc. · 2009
Most influential descendants
Showing 1 of 1 · See all- K083522Sony UP-DF750 Digital Film ImagerSony Electronics, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K002146 | Kodak Dryview 8610 Laser Imager / for Mammography | Eastman Kodak Company | 2000 | — |
| −2 | K012941 | Drystar, Model 4500M | Agfa Corp. | 2001 | — |
| −1 | K021054 | Codonics Horizon CI Medical Multimedia Dry Imager; Codonics Horizon GS Medical… | Codonics, Inc. | 2002 | — |
| 0 (this device) | K024188 | UP-DF500 Filmstation Digital Film Imager | Sony Medical Systems | 2003 | — |
| +1 | K083522 | Sony UP-DF750 Digital Film Imager | Sony Electronics, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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? (4)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K010275 | Drystar 4500 Printer, Model 4500 | 2001 |
| * | K021054 | Codonics Horizon CI Medical Multimedia Dry Imager; Codonics Horizon GS Medical… | 2002 |
| * | K962967 | Fuji Medical Dry Imager FM-DP 2636Summary page 1…Imagers Codonics, Inc. KO2 1054 Fuji Medical Dry Imager FM-DP 2636 Fuji Medical Systems-USA, Inc. K962967 0 KODAK DRY VIEW 86 10 Laser Imager Eastman Kodak Company KO02 146 Sony Medical Syst… | 1996 |
| Kept off the family tree | K020146 | FDA’s K020146 is Serralnyl Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083522 | Sony UP-DF750 Digital Film Imager | 2009 | 0 |
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 3 years and passes through 4 companies; a new generation was cleared every 9 months on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K083522 (Sony Electronics, Inc., 2009) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K010275.
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 Sony UP-DFSOO FilmStationTMDigital Film Imager is a thermal printer intended for use in printing high-resolution diagnostic images from CT, MRI or other compatible medical imaging systems. The Sony UP-DFSOO is intended for use by medical radiologists or other appropriately trained medical personnel.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K024188 · printed Nov 6, 2026
Cite this page
510(k) Report. “K024188: UP-DF500 Filmstation Digital Film Imager.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K024188
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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