510(k) · Cleared

Cleared

Film Digitizer Model 2905

K982785510(k) TraditionalCleared Oct 15, 199869-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

Array Corp. · LMA Digitizer, Image, Radiological

Cleared on Oct 15, 1998 as substantially equivalent to K933129 (Lumisys, Inc., 1993) and 1 other predicate after a 69-day review. Its family tree reaches back 1 generation to 1993. 1 later device descends from it.

Decided: Oct 15, 1998
Review: 69 days
Class: Class II
Product code: LMA
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K933129 (1993). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK933129 Lumiscan 50Lumisys, Inc. · 1993
This deviceK982785 Film Digitizer Model 2905Array Corp. · 1998
Descendant · cites it directly · 0 of its ownK984252 Imation Trimatic Digital SystemImation Corp. · 1999

Most influential descendants

Showing 1 of 1 · See all

K984252Imation Trimatic Digital SystemImation Corp. · 1999 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K933129	Lumiscan 50	Lumisys, Inc.	1993	—
0 (this device)	K982785	Film Digitizer Model 2905	Array Corp.	1998	—
+1	K984252	Imation Trimatic Digital System	Imation Corp.	1999	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0

FIG. 1 — Lineage of K982785, 1993–1999Source: 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? (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	Applicant	Decided	Recalls
*	K933129	Lumiscan 50 Summary page 1 …ssification Medical image digitizers were reviewed by the Radiology Panel and are classified in Class II per 21 CFR 892.2030. . Predicate Device . Lumiscan 50, 510(k)# K933129, Lumiscan 20, 510(k)# K953964, manufactured by Lumisys Inc., 225 Humboldt Court, Sunnyvale, California 94089. . Description of D…	Lumisys, Inc.	1993	—
*	K953964	Lumisys, Lumiscan 20 Summary page 1 …itizers were reviewed by the Radiology Panel and are classified in Class II per 21 CFR 892.2030. . Predicate Device . Lumiscan 50, 510(k)# K933129, Lumiscan 20, 510(k)# K953964, manufactured by Lumisys Inc., 225 Humboldt Court, Sunnyvale, California 94089. . Description of Device The Laser Film Digitize…	Lumisys, Inc.	1995	—

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
K984252	Imation Trimatic Digital System	Imation Corp.	1999	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, K984252 (Imation Corp., 1999) has gone furthest, with 0 descendants of its own.

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 Laser Film Digitizer 2905 is indicated for scanning medical radiographs

with a laser beam and generating a digital electrical signal from the

transmitted light.

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/K982785 · printed Nov 4, 2026

Cite this page

510(k) Report. “K982785: Film Digitizer Model 2905.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982785

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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