510(k) · Cleared
ClearedDigital Printer P6000D Series, Model P6000DU
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mitsubishi Electric Corporation Kyoto Works · LMC Camera, Multi Format, Radiological
Cleared on Jun 23, 2006 as substantially equivalent to K032635 (Agfa Corp., 2003) after a 44-day review. Its family tree reaches back 3 generations to 2001.
- Decided
- Jun 23, 2006
- Review
- 44 days
- Class
- Class II
- Product code
- LMC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K010275 (2001). 4 ancestors in all, the oldest K943602 (1995). No later device cites it as a predicate yet.
- Root · 3 generations backK010275 Drystar 4500 Printer, Model 4500Agfa Medical Imaging · 2001
- 2 generations backK023287 Drystar 5500Agfa Corp. · 2002
- 1 generation backK032635 Drystar 5300 Medical Image Printer, Model 5300Agfa Corp. · 2003
- This deviceK061302 Digital Printer P6000D Series, Model P6000DUMitsubishi Electric Corporation Kyoto Works · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K010275 | Drystar 4500 Printer, Model 4500 | Agfa Medical Imaging | 2001 | — |
| −2 | K023287 | Drystar 5500 | Agfa Corp. | 2002 | — |
| −1 | K032635 | Drystar 5300 Medical Image Printer, Model 5300 | Agfa Corp. | 2003 | — |
| 0 (this device) | K061302 | Digital Printer P6000D Series, Model P6000DU | Mitsubishi Electric Corporation Kyoto Works | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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 |
|---|---|---|---|
| * | K032635 | Drystar 5300 Medical Image Printer, Model 5300Summary page 2…Collateral standard: Electromagnetic compatibility - Requirements and tests 12. Predicate Device Drystar 5300M manufactured by Agfa Corporation, 510(k) No.: K032635. 13. Technological Characteristics Digital Printer P6000D series Model P6000DU has same technological characteristics as… | 2003 |
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?
- The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- None of the 4 ancestors has a recall.
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?
Digital Printer P6000D series Model P6000DU receives signals from diagnostic imaging equipment or a personal computer, and automatically prints and ejects the received image data on the film/thermal paper. This device is not intended for mammography use.
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/K061302 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061302: Digital Printer P6000D Series, Model P6000DU.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061302
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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