510(k) · Cleared
Recalled · 2008Drystar Axys, Model EYZ4E
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Agfa Healthcare Corporation · LMC Camera, Multi Format, Radiological
Cleared on Oct 25, 2007 as substantially equivalent to K023287 (Agfa Corp., 2002) after a 31-day review. Its family tree reaches back 2 generations to 2001. 1 later device descends from it. It has been recalled once.
- Decided
- Oct 25, 2007
- Review
- 31 days
- Class
- Class II
- Product code
- LMC
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K010275 (2001). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK010275 Drystar 4500 Printer, Model 4500Agfa Medical Imaging · 2001
- 1 generation backK023287 Drystar 5500Agfa Corp. · 2002
- This deviceK072680 Drystar Axys, Model EYZ4EAgfa Healthcare Corporation · 2007
- 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 |
|---|---|---|---|---|---|
| −2 | K010275 | Drystar 4500 Printer, Model 4500 | Agfa Medical Imaging | 2001 | — |
| −1 | K023287 | Drystar 5500 | Agfa Corp. | 2002 | — |
| 0 (this device) | K072680 | Drystar Axys, Model EYZ4E | Agfa Healthcare Corporation | 2007 | — |
| +1 | K083522 | Sony UP-DF750 Digital Film Imager | Sony Electronics, Inc. | 2009 | — |
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? (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 |
|---|---|---|---|
| * | K023287 | Drystar 5500Summary page 1…reenville, SC 29601 Prepared: September 19, 2007 A. Legally Marketed Predicate Devices. The Drystar 5500 printer is legally marketed (cleared) under 510(k) number K023287. The new Drystar AXYS, the subject of the present 510(k), is very similar to the cleared Drystar 5500 in both hardware and sof… | 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 16, 2008 | Not classified | Z-2136-2008 | Other | The "Film Calibration" setting on the printers was set to the default "OFF" position instead of "ON". |
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 2 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 K023287.
How does its category compare?
All LMC devicesLMC Camera, Multi Format, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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 AXYS is a free standing device used to print diagnostic conventional and mammography 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/K072680 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072680: Drystar Axys, Model EYZ4E.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072680
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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