510(k) · Cleared
ClearedDrystar 5500
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Agfa Corp. · LMC Camera, Multi Format, Radiological
Cleared on Oct 22, 2002 as substantially equivalent to K010275 (Agfa Medical Imaging, 2001) after a 20-day review. Its family tree reaches back 1 generation to 2001. 5 later devices descend from it.
- Decided
- Oct 22, 2002
- Review
- 20 days
- Class
- Class II
- Product code
- LMC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K010275 (2001). 5 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK010275 Drystar 4500 Printer, Model 4500Agfa Medical Imaging · 2001
- This deviceK023287 Drystar 5500Agfa Corp. · 2002
- Descendant · cites it directly · 1 of its ownK072680 Drystar Axys, Model EYZ4EAgfa Healthcare Corporation · 2007 · Recalled
- Descendant · cites it directly · 1 of its ownK032635 Drystar 5300 Medical Image Printer, Model 5300Agfa Corp. · 2003
- Descendant · 2 generations on · 0 of its ownK083522 Sony UP-DF750 Digital Film ImagerSony Electronics, Inc. · 2009
- Descendant · 2 generations on · 0 of its ownK061302 Digital Printer P6000D Series, Model P6000DUMitsubishi Electric Corporation Kyoto Works · 2006
- Descendant · cites it directly · 0 of its ownK052251 Drystar Model 5500Agfa Corporation · 2005
Most influential descendants
Showing 5 of 5 · See all- K072680Drystar Axys, Model EYZ4EAgfa Healthcare Corporation · 2007 · cites it directly1descendant
- K032635Drystar 5300 Medical Image Printer, Model 5300Agfa Corp. · 2003 · cites it directly1descendant
- K083522Sony UP-DF750 Digital Film ImagerSony Electronics, Inc. · 2009 · 2 generations on0descendants
- K061302Digital Printer P6000D Series, Model P6000DUMitsubishi Electric Corporation Kyoto Works · 2006 · 2 generations on0descendants
- K052251Drystar Model 5500Agfa Corporation · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K010275 | Drystar 4500 Printer, Model 4500 | Agfa Medical Imaging | 2001 | — |
| 0 (this device) | K023287 | Drystar 5500 | Agfa Corp. | 2002 | — |
| +1 | K072680 | Drystar Axys, Model EYZ4E | Agfa Healthcare Corporation | 2007 | 1 |
| +1 | K032635 | Drystar 5300 Medical Image Printer, Model 5300 | Agfa Corp. | 2003 | — |
| +2 | K083522 | Sony UP-DF750 Digital Film Imager | Sony Electronics, Inc. | 2009 | — |
| +2 | K061302 | Digital Printer P6000D Series, Model P6000DU | Mitsubishi Electric Corporation Kyoto Works | 2006 | — |
| +1 | K052251 | Drystar Model 5500 | Agfa Corporation | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K010275 | Drystar 4500 Printer, Model 4500 | 2001 |
What descends from it? (5)
3 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?
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 Drystar 5500 is a free-standing printer used to print diagnostic images on transparent film for viewing on a standard view box. It may be used in any situation in which a hard copy of an image generated by a medical imaging device is required or desirable.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023287 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023287: Drystar 5500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023287
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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