510(k) · Cleared
ClearedDI-2000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lumisys, Inc. · LMA Digitizer, Image, Radiological
Cleared on Mar 17, 1998 as substantially equivalent to K972191 (Howtek, Inc., 1997) and 3 other predicates after a 67-day review. Its family tree reaches back 2 generations to 1995. 5 later devices descend from it.
- Decided
- Mar 17, 1998
- Review
- 67 days
- Class
- Class II
- Product code
- LMA
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K952914 (1995). 5 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK952914 Star Technologies, Inc. Film Image Scan SystemStar Technologies, Inc. · 1995
- 1 generation backK972191 Digitizer Director (HSC025-01)Howtek, Inc. · 1997
- This deviceK980213 DI-2000Lumisys, Inc. · 1998
- Descendant · cites it directly · 3 of its ownK020243 Laserpro 16Eradlink, Inc. · 2002
- Descendant · 2 generations on · 2 of its ownK052938 CR-PROEradlink, Inc. · 2005
- Descendant · 2 generations on · 1 of its ownK142718 Radlink GPSRadlink, Inc. · 2014
- Descendant · 3 generations on · 0 of its ownK242161 Radlink GPS Pro ImagingRadlink, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK012155 Kodak Radiation Oncology Software/ for Acr SystemsEastman Kodak Company · 2001
Most influential descendants
Showing 5 of 5 · See all- K020243Laserpro 16Eradlink, Inc. · 2002 · cites it directly3descendants
- K052938CR-PROEradlink, Inc. · 2005 · 2 generations on2descendants
- K142718Radlink GPSRadlink, Inc. · 2014 · 2 generations on1descendant
- K242161Radlink GPS Pro ImagingRadlink, Inc. · 2025 · 3 generations on0descendants
- K012155Kodak Radiation Oncology Software/ for Acr SystemsEastman Kodak Company · 2001 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K952914 | Star Technologies, Inc. Film Image Scan System | Star Technologies, Inc. | 1995 | — |
| −1 | K972191 | Digitizer Director (HSC025-01) | Howtek, Inc. | 1997 | — |
| 0 (this device) | K980213 | DI-2000 | Lumisys, Inc. | 1998 | — |
| +1 | K020243 | Laserpro 16 | Eradlink, Inc. | 2002 | — |
| +2 | K052938 | CR-PRO | Eradlink, Inc. | 2005 | — |
| +2 | K142718 | Radlink GPS | Radlink, Inc. | 2014 | — |
| +3 | K242161 | Radlink GPS Pro Imaging | Radlink, Inc. | 2025 | — |
| +1 | K012155 | Kodak Radiation Oncology Software/ for Acr Systems | Eastman Kodak Company | 2001 | — |
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 |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 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? (4)
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 |
|---|---|---|---|
| * | K972191 | Digitizer Director (HSC025-01)Summary page 4…tially equivalent to the following medical devices in commercial distribution: Manufacturer Product (Trade Name) S10(k)# Decision Date Howtek, Inc. Digitizer Director ™ K972191 9/8/97 DelJarnette Research ImageShare Film Digitizer 1000™ K963628 11/7/96 Systems DeJarnette Research ImageShare Secondary Capt… | 1997 |
| * | K963628 | Imageshare Computed Radiography Acquisition Station and/or SoftwareSummary page 4…tribution: Manufacturer Product (Trade Name) S10(k)# Decision Date Howtek, Inc. Digitizer Director ™ K972191 9/8/97 DelJarnette Research ImageShare Film Digitizer 1000™ K963628 11/7/96 Systems DeJarnette Research ImageShare Secondary Capture K963594 11/7/96 Systems Acquisition Station; ImageShare Computed… | 1996 |
| * | K963594 | Imageshare Secondary Capture Acquisition Station and/or Software (1000 Film Digitizer…Summary page 4…k, Inc. Digitizer Director ™ K972191 9/8/97 DelJarnette Research ImageShare Film Digitizer 1000™ K963628 11/7/96 Systems DeJarnette Research ImageShare Secondary Capture K963594 11/7/96 Systems Acquisition Station; ImageShare Computed Radiography Acquisition Station Mitra Imaging, Inc. Film Express K970652… | 1996 |
| * | K970652 | Mitra Imaging, Inc. Film Express Scanning SoftwareSummary page 4…e Research ImageShare Secondary Capture K963594 11/7/96 Systems Acquisition Station; ImageShare Computed Radiography Acquisition Station Mitra Imaging, Inc. Film Express K970652 5/2/97 Feature Comparison Feature DI-2000 Digitizer ImageShare™ | Film Express Director™ Bulk Transfer Y N N N DICOM 3.0 Compl… | 1997 |
What descends from it? (5)
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 3 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K020243 (Eradlink, Inc., 2002) has gone furthest, with 3 descendants of its own.
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?
DI-2000 is intended to utilize a scanner and software interface to digitize either radiology film or computed radiography exposed phosphor plates. DI-2000 is a DICOM 3.0 compliant radiological digitization application. DI-2000 enables the user to autoarchive lossless or lossy compressed images locally or at a remote archive site. Supports DICOM 3.0 Query and Retrieve Service Class. Supports scanning of films or phosphor plates in batch mode prior to…
Read the full statement (125 words)
DI-2000 is intended to utilize a scanner and software interface to digitize either radiology film or computed radiography exposed phosphor plates.
DI-2000 is a DICOM 3.0 compliant radiological digitization application.
DI-2000 enables the user to autoarchive lossless or lossy compressed images locally or at a remote archive site. Supports DICOM 3.0 Query and Retrieve Service Class.
Supports scanning of films or phosphor plates in batch mode prior to entering patient information. Once scanned, images can be sent to multiple destinations.
Users:
The DI-2000 will be located in a radiology department or clinic, or in a mobile radiology van. DI-2000 will support reading and digitizing exposed CR plates or radiology film. The expected users are as follows:
Radiologists
Radiology Technologists
System Administrator within the radiology department
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/K980213 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980213: DI-2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980213
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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