510(k) · Cleared

Cleared

Visix Imaging

K082623510(k) TraditionalCleared Feb 25, 2009169-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

Televere Systems · LLZ System, Image Processing, Radiological

Cleared on Feb 25, 2009 as substantially equivalent to K061035 (Televere Systems, 2006) and 2 other predicates after a 169-day review. Its family tree reaches back 3 generations to 1993. 9 later devices descend from it.

Decided: Feb 25, 2009
Review: 169 days
Class: Class II
Product code: LLZ
Recalls: None
Predicates: 3

Its longest line of descent runs back 3 generations to K930527 (1993). 4 ancestors in all. 9 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 3 generations backK930527 Dental LinkEscan, Inc. · 1993
2 generations backK955237 Tigerscan/TigerviewTau Corp. · 1996
1 generation backK061035 Tigerview ProfessionalTelevere Systems · 2006
This deviceK082623 Visix ImagingTelevere Systems · 2009
Descendant · cites it directly · 7 of its ownK143290 DBSWIN and VistaEasy Imaging SoftwareDurr Dental AG · 2016
Descendant · 2 generations on · 6 of its ownK161444 DBSWIN and VistaEasy Imaging SoftwareDuerr Dental AG · 2016
Descendant · 3 generations on · 5 of its ownK190629 DBSWIN and VISTAEASY Imaging SoftwareDurr Dental SE · 2019
Descendant · 4 generations on · 3 of its ownK192743 VisionX 2.4Durr Dental SE · 2019
Descendant · 5 generations on · 2 of its ownK213326 VisionX 3.0Durr Dental SE · 2021

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2010high 2 (2016) · low 0 (2011)2026

Most influential descendants

Showing 5 of 9 · See all

K143290DBSWIN and VistaEasy Imaging SoftwareDurr Dental AG · 2016 · cites it directly7descendants
K161444DBSWIN and VistaEasy Imaging SoftwareDuerr Dental AG · 2016 · 2 generations on6descendants
K190629DBSWIN and VISTAEASY Imaging SoftwareDurr Dental SE · 2019 · 3 generations on5descendants
K192743VisionX 2.4Durr Dental SE · 2019 · 4 generations on3descendants
K213326VisionX 3.0Durr Dental SE · 2021 · 5 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K930527	Dental Link	Escan, Inc.	1993	—
−2	K955237	Tigerscan/Tigerview	Tau Corp.	1996	—
−1	K061035	Tigerview Professional	Televere Systems	2006	—
0 (this device)	K082623	Visix Imaging	Televere Systems	2009	—
+1	K143290	DBSWIN and VistaEasy Imaging Software	Durr Dental AG	2016	—
+2	K161444	DBSWIN and VistaEasy Imaging Software	Duerr Dental AG	2016	—
+3	K190629	DBSWIN and VISTAEASY Imaging Software	Durr Dental SE	2019	—
+4	K192743	VisionX 2.4	Durr Dental SE	2019	—
+5	K213326	VisionX 3.0	Durr Dental SE	2021	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	1	0
2016	2	0
2019	2	0
2020	1	0
2021	1	0
2025	1	0
2026	1	0

FIG. 1 — Lineage of K082623, 1993–2026Source: 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? (3)

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
*	K061035	Tigerview Professional Summary page 1 …Predicate Device Manufacturer Product Name 510(k) No. Televere Systems TigerView Professional K061035 EagleSoft EagleSoft ChairSide Software K982422 Application…	Televere Systems	2006	—
*	K982422	Eaglesoft Chairside Summary page 1 …510(k) No. Televere Systems TigerView Professional K061035 EagleSoft EagleSoft ChairSide Software K982422 Application Tau Corp. (purchased by TigerScan/TigerView K955237…	Eaglesoft, A Patterson Co.	1998	—
*	K955237	Tigerscan/Tigerview Summary page 1 …EagleSoft ChairSide Software K982422 Application Tau Corp. (purchased by TigerScan/TigerView K955237 Televere Systems) August 29, 2008 Televere Systems…	Tau Corp.	1996	—

Also cleared against K061035: 4 other devices →

What descends from it? (9)

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

Number	Device	Applicant	Decided	Descendants
K143290	DBSWIN and VistaEasy Imaging Software	Durr Dental AG	2016	7
K101654	Improvis Imaging System	American Dental Partners, Inc.	2010	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?

The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
None of the 4 ancestors has a recall.
Of its descendants, K143290 (Durr Dental AG, 2016) has gone furthest, with 7 descendants of its own.
4 other devices also cite its predicate K061035.

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. 2009, this device’s year, is highlighted.

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?

Visix Imaging is a clinical software application that receives images and data from various imaging sources (e.g., radiographic devices, digital video capture devices, and generic image devices such as scanners). Visix Imaging is intended to acquire, display, edit (e.g., resize, adjust contrast, annotate, etc.), review, store, print, and distribute, images, plus store clinical notes in the form of annotations and measurements, using standard PC hardware. Visix Imaging is currently intended for dental use. It is not intended for mammography use.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K082623 · printed Nov 5, 2026

Cite this page

510(k) Report. “K082623: Visix Imaging.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082623

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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