510(k) · Cleared

Cleared

Netco Medical Data Transportation Service Software

K980241510(k) TraditionalCleared Mar 17, 199853-day reviewClass I21 CFR 892.2020

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

Netco Communications Corp. · LMD System, Digital Image Communications, Radiological

Cleared on Mar 17, 1998 as substantially equivalent to K963395 (Sectra-Imtec AB, 1996) and 1 other predicate after a 53-day review. Its family tree reaches back 2 generations to 1993.

Decided: Mar 17, 1998
Review: 53 days
Class: Class I
Product code: LMD
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K922164 (1993). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK922164 Raytel Digital Imaging SystemsOlicon Imaging Systems, Inc. · 1993
1 generation backK963395 Imageserver 2000 Picture Archiving SystemSectra-Imtec AB · 1996
This deviceK980241 Netco Medical Data Transportation Service SoftwareNetco Communications Corp. · 1998

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K922164	Raytel Digital Imaging Systems	Olicon Imaging Systems, Inc.	1993	—
−1	K963395	Imageserver 2000 Picture Archiving System	Sectra-Imtec AB	1996	—
0 (this device)	K980241	Netco Medical Data Transportation Service Software	Netco Communications Corp.	1998	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1993	1	0

FIG. 1 — Lineage of K980241, 1993–1998Source: 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 LMD? 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
*	K963395	Imageserver 2000 Picture Archiving System Summary page 1 …Register Monday, December 2, 1996 Vol. 61, No. 232 p 63769 (Proposed rule) Docket No. 96-30650) 3. Predicate devices Sectra Imageserver 2000 Picture Archiving System [K963395] AGFA IMPAX 3000 [K934832] * 4. Device Description The DICOM storage service class functionality is provided by two applicatio…	Sectra-Imtec AB	1996	—
*	K934832	IMPAX 3000 Summary page 1 …2, 1996 Vol. 61, No. 232 p 63769 (Proposed rule) Docket No. 96-30650) 3. Predicate devices Sectra Imageserver 2000 Picture Archiving System [K963395] AGFA IMPAX 3000 [K934832] * 4. Device Description The DICOM storage service class functionality is provided by two applications that execute on the NAD…	Heraeus Kulzer, Inc.	1993	—

Also cleared against K963395: 1 other device →

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 5 years and passes through 3 companies; a new generation was cleared every 3.8 years on median.
None of the 3 ancestors has a recall.
1 other device also cites its predicate K963395.

How does its category compare?

All LMD devices

LMD System, Digital Image Communications, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LMD

FDA has decided no LMD device since 2007.

Median 510(k) review, days · LMD

Too few LMD 510(k)s in any year since 2007 to give a median.

Recalls per year · LMD

2in 2020

2007high 2 (2007) · low 0 (2010)2026

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

Adverse event reports per year · LMD

16in 2025

2007high 16 (2025) · low 1 (2007)2025

MAUDE reports naming product code LMD, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	2	1
2008	—	1	2
2009	—	1	3
2010	—	0	9
2011	—	0	1
2012	—	1	2
2013	—	0	4
2014	—	0	12
2015	—	1	9
2016	—	0	3
2017	—	0	2
2018	—	0	4
2019	—	0	2
2020	—	2	2
2021	—	0	2
2022	—	0	6
2023	—	0	7
2024	—	0	8
2025	—	0	16
2026	—	0	—

What is it indicated for?

The NetCo MDTS software is intended to be used in the transportation, storage, and

retrieval of digital patient files.

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/K980241 · printed Nov 5, 2026

Cite this page

510(k) Report. “K980241: Netco Medical Data Transportation Service Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K980241

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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