510(k) · Cleared

Cleared

Digmi-2000 (Gsi Internal Reference)/LD2800 (Marketing Name)

K973411510(k) TraditionalCleared Dec 4, 199786-day reviewClass II21 CFR 892.2030

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

General Scanning, Inc. · LMA Digitizer, Image, Radiological

Cleared on Dec 4, 1997 as substantially equivalent to K901423 (Lumisys, Inc., 1990) and 1 other predicate after an 86-day review. Its family tree reaches back 1 generation to 1990. 1 later device descends from it.

Decided: Dec 4, 1997
Review: 86 days
Class: Class II
Product code: LMA
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K901423 (1990). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK901423 Digital Image Scanner, Model Dis-1000Lumisys, Inc. · 1990
This deviceK973411 Digmi-2000 (Gsi Internal Reference)/LD2800 (Marketing Name)General Scanning, Inc. · 1997
Descendant · cites it directly · 0 of its ownK980565 LD2000 SeriesGeneral Scanning, Inc. · 1998

Most influential descendants

Showing 1 of 1 · See all

K980565LD2000 SeriesGeneral Scanning, Inc. · 1998 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K901423	Digital Image Scanner, Model Dis-1000	Lumisys, Inc.	1990	—
0 (this device)	K973411	Digmi-2000 (Gsi Internal Reference)/LD2800 (Marketing Name)	General Scanning, Inc.	1997	—
+1	K980565	LD2000 Series	General Scanning, Inc.	1998	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1993	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0

FIG. 1 — Lineage of K973411, 1990–1998Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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What was it cleared against? (5)

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	Applicant	Decided	Recalls
*	K901423	Digital Image Scanner, Model Dis-1000 Summary page 1 …Name Film Digitizer Trade/Proprietary Name DigMi-2000 (Internal to GSI) LD2800 (Marketing Name) Substantial Equivalence - Predicate Devices Lumiscan 85LF Lumiscan 100 K901423 Konica K933£830 Nishimoto Sangyo ED-2000 Nishimoto Sangyo ED-3500 Device Description and “Statement of Indications For Use” The…	Lumisys, Inc.	1990	—
*	K933830	Konica LD-4500 Laser Digitizer	Konica Medical Corp.	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			—

Also cleared against K901423: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K980565	LD2000 Series	General Scanning, Inc.	1998	0

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?

None of the 2 ancestors has a recall.
Of its descendants, K980565 (General Scanning, Inc., 1998) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K901423.

How does its category compare?

All LMA devices

LMA Digitizer, Image, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LMA

3in 2013

2007high 3 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LMA

80in 2013

2007high 80 (2013)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LMA

1in 2019

2007high 1 (2019) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LMA

1in 2013

2007high 3 (2008) · low 0 (2007)2025

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 LD2800 laser film digitizer is intended to create copies of medical images stored on film when connected to a laser imager. It is intended for use in making copies of conventional x-ray films as well as films produced by imagers that fall in the ranges specified for size and optical density range detailed in the specifications.

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/K973411 · printed Nov 4, 2026

Cite this page

510(k) Report. “K973411: Digmi-2000 (Gsi Internal Reference)/LD2800 (Marketing Name).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973411

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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