510(k) · Cleared
ClearedLaser Imager Drypro Model 873
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 Jul 1, 2008 as substantially equivalent to K042133 (Konica Minolta Medical & Graphic, Inc., 2004) after a 20-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- Jul 1, 2008
- Review
- 20 days
- Class
- Class II
- Product code
- LMC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K002146 (2000). No later device cites it as a predicate yet.
- Root · 3 generations backK002146 Kodak Dryview 8610 Laser Imager / for MammographyEastman Kodak Company · 2000
- 2 generations backK033821 Kodak Dryview 8900 Laser Imager Mammography AccessoryEastman Kodak Company · 2004
- 1 generation backK042133 Dry Laser Imager, Model Drypro Model 793Konica Minolta Medical & Graphic, Inc. · 2004
- This deviceK081637 Laser Imager Drypro Model 873Konica Minolta Medical & Graphic, Inc. · 2008
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 | K033821 | Kodak Dryview 8900 Laser Imager Mammography Accessory | Eastman Kodak Company | 2004 | — |
| −1 | K042133 | Dry Laser Imager, Model Drypro Model 793 | Konica Minolta Medical & Graphic, Inc. | 2004 | — |
| 0 (this device) | K081637 | Laser Imager Drypro Model 873 | Konica Minolta Medical & Graphic, Inc. | 2008 | — |
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 |
|---|---|---|---|
| * | K042133 | Dry Laser Imager, Model Drypro Model 793Summary page 1…cation Class HI, 21 CFR 892. 2040, Medical image hardcopy device 7. Product Code 90 LMC 8. Predicate Device DRY LASER IMAGER, DRYPRO MODEL 793, 510(k) Number: K042133 .3I 9. Description of Device The LASER IMAGER, DRYPRO MODEL 873 is a Medic… | 2004 |
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 8 years and passes through 2 companies; a new generation was cleared every 3.4 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K042133.
How does its category compare?
All LMC devicesLMC Camera, Multi Format, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 LASER IMAGER, DRYPRO MODEL 873 is intended to be used to acquire images from diagnostic equipment such as CT, MRI, DSA or FDA-approved Full Field Digital Mammography System and print the images on medical dry-film.
The devices are intended to be used by trained medical personnel in a clinic or hospital environment
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081637 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081637: Laser Imager Drypro Model 873.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081637
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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