510(k) · Cleared
ClearedDry Laser Imager, Drypro Model 832
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Konica Minolta Medical & Graphic, Inc. · LMC Camera, Multi Format, Radiological
Cleared on Aug 15, 2006 as substantially equivalent to K032681 (Konica Medical and Graphic Corporation, 2003) after a 32-day review. Its family tree reaches back 1 generation to 2003.
- Decided
- Aug 15, 2006
- Review
- 32 days
- Class
- Class II
- Product code
- LMC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K032681 (2003). No later device cites it as a predicate yet.
- Root · 1 generation backK032681 Konica Laser Imager, Model Drypro Model 771Konica Medical and Graphic Corporation · 2003
- This deviceK061999 Dry Laser Imager, Drypro Model 832Konica Minolta Medical & Graphic, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K032681 | Konica Laser Imager, Model Drypro Model 771 | Konica Medical and Graphic Corporation | 2003 | — |
| 0 (this device) | K061999 | Dry Laser Imager, Drypro Model 832 | Konica Minolta Medical & Graphic, Inc. | 2006 | — |
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 |
|---|---|---|---|
| * | K032681 | Konica Laser Imager, Model Drypro Model 771Summary page 2…copy device 8. Product Cord 90 LMC 2- I 9. Predicate Device Konica Laser Imager, DRYPRO Model 771, 510(K) No.: K032681 Comparison of the principal characteristics of the two devices which are pertinent to Specification performance is attached.… | 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?
- Its one ancestor has no 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?
The Dry Laser Imager, DRYPRO Model 832 is intended to be used to receive image data from diagnostic equipment such as CT, MRI, DSA and other medical devices and print them on medical dry-film. The output image is not a high resolution and DRYPRO Model 832 is not intended for use with FFDM systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061999 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061999: Dry Laser Imager, Drypro Model 832.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061999
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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