510(k) · Cleared
ClearedLD2000 Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
General Scanning, Inc. · LMA Digitizer, Image, Radiological
Cleared on Mar 19, 1998 as substantially equivalent to K973411 (General Scanning, Inc., 1997) and 2 other predicates after a 34-day review. Its family tree reaches back 2 generations to 1990.
- Decided
- Mar 19, 1998
- Review
- 34 days
- Class
- Class II
- Product code
- LMA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K901423 (1990). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K901423 | Digital Image Scanner, Model Dis-1000 | Lumisys, Inc. | 1990 | — |
| −1 | K973411 | Digmi-2000 (Gsi Internal Reference)/LD2800 (Marketing Name) | General Scanning, Inc. | 1997 | — |
| 0 (this device) | K980565 | LD2000 Series | General Scanning, Inc. | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 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? (6)
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 |
|---|---|---|---|
| * | K973411 | Digmi-2000 (Gsi Internal Reference)/LD2800 (Marketing Name)Summary page 1…ogy Device Common Name Laser Film Digitizer Trade/Proprietary Name LD2000 SERIES (Marketing Name) Substantial Equivalence - Predicate Devices General Scanning LD2800 K973411 Lumiscan 85LF Lumiscan 100 K901423 Konica K9333830 Nishimoto Sangyo ED-2000 Nishimoto Sangyo ED-3500 Device Description and “S… | 1997 |
| * | K901423 | Digital Image Scanner, Model Dis-1000Summary page 1…igitizer Trade/Proprietary Name LD2000 SERIES (Marketing Name) Substantial Equivalence - Predicate Devices General Scanning LD2800 K973411 Lumiscan 85LF Lumiscan 100 K901423 Konica K9333830 Nishimoto Sangyo ED-2000 Nishimoto Sangyo ED-3500 Device Description and “Statement of Indications For Use” Th… | 1990 |
| * | K933830 | Konica LD-4500 Laser Digitizer | 1993 |
| * | — | Lumiscan 85LF Named without a submission number | |
| * | — | Nishimoto Sangyo ED-2000 Named without a submission number | |
| * | — | Nishimoto Sangyo ED-3500 Named without a submission number |
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 7.6 years on median.
- None of the 3 ancestors has a recall.
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 General Scanning model LD2000 SERIES laser film digitizer is intended to convert medical images stored on film to digital data for copying, storage, and transmission. It is intended for use to digitize copies of conventional x-rays and films produced by imagers that fall in the ranges for size and optical density range detailed in the specifications. The digitizer utilizes laser light to scan the film, extracts the image data by measuring the…
Read the full statement (147 words)
The General Scanning model LD2000 SERIES laser film digitizer is intended to convert medical images stored on film to digital data for copying, storage, and transmission. It is intended for use to digitize copies of conventional x-rays and films produced by imagers that fall in the ranges for size and optical density range detailed in the specifications.
The digitizer utilizes laser light to scan the film, extracts the image data by measuring the transmitted light, converts it into digital form, and transmits the data over a digital link. The digitized information may then be transmitted to a Laser Imager for printed hardcopy or to a Work Station for use in Teleradiology (transmission of images) or PACS (Picture Archiving Communication Systems).
The LD2000 SERIES contains the scanning laser and detection module, a film transport, and electronics to convert and transmit the image data and provide control and calibration.
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/K980565 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980565: LD2000 Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980565
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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