510(k) · Cleared

Cleared

View NT

K000474510(k) AbbreviatedCleared Apr 19, 200065-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

Electromed Intl., Ltd. · LLZ System, Image Processing, Radiological

Cleared on Apr 19, 2000 after a 65-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 66 later devices descend from it.

Decided: Apr 19, 2000
Review: 65 days
Class: Class II
Product code: LLZ
Recalls: None
Predicates: 0

66 later devices descend from it, 2 citing it directly.

This deviceK000474 View NTElectromed Intl., Ltd. · 2000
Descendant · cites it directly · 64 of its ownK012093 Aetmed Image Processing SoftwareAetmed, S.P.A. · 2001
Descendant · 2 generations on · 61 of its ownK013694 Nidek Advanced Vision Information System (Navis)Nidek, Inc. · 2002
Descendant · 3 generations on · 50 of its ownK082364 Imagenet Professional PC Software System or Imagenet Professional…Topcon Corp. · 2008
Descendant · 3 generations on · 32 of its ownK090439 FORUMCarl Zeiss Meditec, Inc. · 2009
Descendant · 3 generations on · 29 of its ownK093313 SynergyTopcon Medical Systems, Inc. · 2009

Showing 5 of 66 descendants. See all descendants

Descendants cleared per year

2001high 8 (2017) · low 0 (2005)2026

Most influential descendants

Showing 5 of 66 · See all

K012093Aetmed Image Processing SoftwareAetmed, S.P.A. · 2001 · cites it directly64descendants
K013694Nidek Advanced Vision Information System (Navis)Nidek, Inc. · 2002 · 2 generations on61descendants
K082364Imagenet Professional PC Software System or Imagenet Professional, or Imagenet Pro, or…Topcon Corp. · 2008 · 3 generations on50descendants
K090439FORUMCarl Zeiss Meditec, Inc. · 2009 · 3 generations on32descendants
K093313SynergyTopcon Medical Systems, Inc. · 2009 · 3 generations on29descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K000474	View NT	Electromed Intl., Ltd.	2000	—
+1	K012093	Aetmed Image Processing Software	Aetmed, S.P.A.	2001	—
+2	K013694	Nidek Advanced Vision Information System (Navis)	Nidek, Inc.	2002	—
+3	K082364	Imagenet Professional PC Software System or Imagenet Professional, or Imagenet…	Topcon Corp.	2008	—
+3	K090439	FORUM	Carl Zeiss Meditec, Inc.	2009	—
+3	K093313	Synergy	Topcon Medical Systems, Inc.	2009	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2002	1	0
2003	1	0
2004	1	0
2008	1	0
2009	3	0
2010	1	0
2011	3	0
2012	3	0
2013	4	0
2014	5	0
2015	4	0
2017	8	0
2018	7	0
2019	3	0
2020	5	0
2021	1	0
2022	3	0
2023	5	0
2024	2	0
2025	1	0
2026	3	0

FIG. 1 — Lineage of K000474, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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

Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (66)

See all 66

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K012093	Aetmed Image Processing Software	Aetmed, S.P.A.	2001	64
K031638	Cardio Vascular Information Enhanced Workstation	Electromed Imaging, Inc.	2003	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?

Of its descendants, K012093 (Aetmed, S.P.A., 2001) has gone furthest, with 64 descendants of its own.

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	—

https://510kreport.com/device/K000474 · printed Nov 6, 2026

Cite this page

510(k) Report. “K000474: View NT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000474

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026