510(k) · Cleared

Cleared

TRS 2000 Teleradiology System

K961983510(k) TraditionalCleared Aug 13, 199685-day reviewClass II21 CFR 892.2050

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

Sectra-Imtec AB · LLZ System, Image Processing, Radiological

Cleared on Aug 13, 1996 as substantially equivalent to K920950 (Philips Medical Systems, Inc., 1992) after an 85-day review. Its family tree reaches back 1 generation to 1992. 2 later devices descend from it.

Decided: Aug 13, 1996
Review: 85 days
Class: Class II
Product code: LLZ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K920950 (1992). 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK920950 Philips EasyvisionPhilips Medical Systems, Inc. · 1992 · Recalled
This deviceK961983 TRS 2000 Teleradiology SystemSectra-Imtec AB · 1996
Descendant · cites it directly · 1 of its ownK971368 IDS4 Image Display System SeriesO Tech, Inc. · 1997
Descendant · 2 generations on · 0 of its ownK991643 IDS4 V3.2 Image Display SystemO Tech, Inc. · 1999

Most influential descendants

Showing 2 of 2 · See all

K971368IDS4 Image Display System SeriesO Tech, Inc. · 1997 · cites it directly1descendant
K991643IDS4 V3.2 Image Display SystemO Tech, Inc. · 1999 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K920950	Philips Easyvision	Philips Medical Systems, Inc.	1992	1
0 (this device)	K961983	TRS 2000 Teleradiology System	Sectra-Imtec AB	1996	—
+1	K971368	IDS4 Image Display System Series	O Tech, Inc.	1997	—
+2	K991643	IDS4 V3.2 Image Display System	O Tech, Inc.	1999	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
1999	1	0

FIG. 1 — Lineage of K961983, 1992–1999Source: 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 LLZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new LLZ device

#1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

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
*	K920950	Philips Easyvision Summary page 1 …rket Notification for the above referenced product contains adequate information and data to enable CDRH to determine substantial equivalence to Philips PMS EasyVision (K920950). This information and data is summarized as follows: 1. The Teleradiology system TRS is subject to and in compliance with the F…	Philips Medical Systems, Inc.	1992	1

Also cleared against K920950: 4 other devices →

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K971368	IDS4 Image Display System Series	O Tech, Inc.	1997	1

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?

Its one ancestor has a recall.
Of its descendants, K971368 (O Tech, Inc., 1997) has gone furthest, with 1 descendant of its own.
4 other devices also cite its predicate K920950.

How does its category compare?

All LLZ devices

LLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LLZ

58in 2025

2007high 106 (2011) · low 51 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LLZ

173in 2025

2007high 173 (2025) · low 36 (2007)2026

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

Recalls per year · LLZ

11in 2025

2007high 64 (2013) · low 2 (2019)2026

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

Adverse event reports per year · LLZ

116in 2025

2007high 15,631 (2014) · low 26 (2023)2025

MAUDE reports naming product code LLZ, 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	76	36	20	152
2008	94	52	32	154
2009	70	62	21	145
2010	51	98	17	145
2011	106	79	30	454
2012	82	87	12	266
2013	95	84	64	1,130
2014	78	89	6	15,631
2015	64	90	16	211
2016	82	90	12	290
2017	78	107	5	104
2018	104	105	7	72
2019	74	107	2	88
2020	81	115	6	82
2021	83	116	3	70
2022	65	137	4	28
2023	87	157	8	26
2024	62	131	6	42
2025	58	173	11	116
2026	45	110	14	—

What is it indicated for?

The TRS 2000 system is a teleradiology system/transmission and advance reviewing station X-ray images. TRS 2000 is used for advanced reviewing and transmission over private or public telecommunications networks of radiological images. Typical users are phycians and nurses at a radiology deparment.

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/K961983 · printed Nov 5, 2026

Cite this page

510(k) Report. “K961983: TRS 2000 Teleradiology System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K961983

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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