510(k) · Cleared
ClearedLaserpro 16
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eradlink, Inc. · LMA Digitizer, Image, Radiological
Cleared on Mar 5, 2002 as substantially equivalent to K980213 (Lumisys, Inc., 1998) after a 41-day review. Its family tree reaches back 3 generations to 1995. 3 later devices descend from it.
- Decided
- Mar 5, 2002
- Review
- 41 days
- Class
- Class II
- Product code
- LMA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K952914 (1995). 6 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK952914 Star Technologies, Inc. Film Image Scan SystemStar Technologies, Inc. · 1995
- 2 generations backK972191 Digitizer Director (HSC025-01)Howtek, Inc. · 1997
- 1 generation backK980213 DI-2000Lumisys, Inc. · 1998
- This deviceK020243 Laserpro 16Eradlink, Inc. · 2002
- Descendant · cites it directly · 2 of its ownK052938 CR-PROEradlink, Inc. · 2005
- Descendant · cites it directly · 1 of its ownK142718 Radlink GPSRadlink, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK242161 Radlink GPS Pro ImagingRadlink, Inc. · 2025
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K952914 | Star Technologies, Inc. Film Image Scan System | Star Technologies, Inc. | 1995 | — |
| −2 | K972191 | Digitizer Director (HSC025-01) | Howtek, Inc. | 1997 | — |
| −1 | K980213 | DI-2000 | Lumisys, Inc. | 1998 | — |
| 0 (this device) | K020243 | Laserpro 16 | Eradlink, Inc. | 2002 | — |
| +1 | K052938 | CR-PRO | Eradlink, Inc. | 2005 | — |
| +1 | K142718 | Radlink GPS | Radlink, Inc. | 2014 | — |
| +2 | K242161 | Radlink GPS Pro Imaging | Radlink, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2014 | 1 | 0 |
| 2025 | 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 LMA? 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? (2)
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 |
|---|---|---|---|
| * | K980213 | DI-2000Summary page 2…egulation 21 CFR 892.2030) (Class II device) PRODUCT CODE: LMA 3) PREDICATE DEVICE: Lumiscan 75 (510(k) number Not Known) DI-2000 (Software application — 510(k) Number K980213) Lumisys Inc. 225 Humboldt Court Sunnyvale, California 94089 (4) DEVICE DESCRIPTION: The eRadLink LaserPro 16 is a digitizing s… | 1998 |
| * | — | Lumiscan 75 Named without a submission number |
What descends from it? (3)
2 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?
- The line of descent spans 7 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K052938 (Eradlink, Inc., 2005) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K980213.
How does its category compare?
All LMA devicesLMA Digitizer, Image, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LMA
3in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · LMA
80in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LMA
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LMA
1in 2013
MAUDE reports naming product code LMA, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 3 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 3 | 80 | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 1 | 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 LaserPro 16 is a desk top laser image digitizer intended to produce digital copies of radiological film in 16 levels of gray scale. The digital copies are transmitted to a Pentium based personal computer (PC) where they may be displayed, processed, or compressed for archiving or transmission via computer networks to other medical facility sites.
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/K020243 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020243: Laserpro 16.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020243
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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