510(k) · Cleared
ClearedTigerview Professional
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Televere Systems · LLZ System, Image Processing, Radiological
Cleared on Jun 5, 2006 as substantially equivalent to K982422 (Eaglesoft, A Patterson Co., 1998) and 1 other predicate after a 52-day review. Its family tree reaches back 2 generations to 1993. 28 later devices descend from it.
- Decided
- Jun 5, 2006
- Review
- 52 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K930527 (1993). 3 ancestors in all. 28 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK930527 Dental LinkEscan, Inc. · 1993
- 1 generation backK955237 Tigerscan/TigerviewTau Corp. · 1996
- This deviceK061035 Tigerview ProfessionalTelevere Systems · 2006
- Descendant · cites it directly · 14 of its ownK140713 Planmeca RomexisPlanmeca Oy · 2014
- Descendant · 2 generations on · 13 of its ownK162799 CliniviewPalodex Group OY · 2017
- Descendant · 3 generations on · 10 of its ownK203156 DTX Studio ClinicNobel Biocare AB · 2020
- Descendant · 4 generations on · 9 of its ownK213562 DTX Studio Clinic 3.0Nobel Biocare AB · 2022
- Descendant · cites it directly · 9 of its ownK082623 Visix ImagingTelevere Systems · 2009
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 28 · See all- K140713Planmeca RomexisPlanmeca Oy · 2014 · cites it directly14descendants
- K162799CliniviewPalodex Group OY · 2017 · 2 generations on13descendants
- K203156DTX Studio ClinicNobel Biocare AB · 2020 · 3 generations on10descendants
- K213562DTX Studio Clinic 3.0Nobel Biocare AB · 2022 · 4 generations on9descendants
- K082623Visix ImagingTelevere Systems · 2009 · cites it directly9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K930527 | Dental Link | Escan, Inc. | 1993 | — |
| −1 | K955237 | Tigerscan/Tigerview | Tau Corp. | 1996 | — |
| 0 (this device) | K061035 | Tigerview Professional | Televere Systems | 2006 | — |
| +1 | K140713 | Planmeca Romexis | Planmeca Oy | 2014 | — |
| +2 | K162799 | Cliniview | Palodex Group OY | 2017 | — |
| +3 | K203156 | DTX Studio Clinic | Nobel Biocare AB | 2020 | — |
| +4 | K213562 | DTX Studio Clinic 3.0 | Nobel Biocare AB | 2022 | — |
| +1 | K082623 | Visix Imaging | Televere Systems | 2009 | — |
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 |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 4 | 0 |
| 2026 | 5 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K982422 | Eaglesoft ChairsideSummary page 1…e Device Manufacturer Product Name 510(k) No. EagleSoft, A Patterson Co. EagleSoft ChairSide Software K982422 Application Tau Corp. TigerScan/TigerView K9… | 1998 |
| * | K955237 | Tigerscan/TigerviewSummary page 1…EagleSoft ChairSide Software K982422 Application Tau Corp. TigerScan/TigerView K955237 April 14, 2006 Televere Systems 510(k) Premarket Notif… | 1996 |
What descends from it? (28)
See all 285 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 13 years and passes through 3 companies; a new generation was cleared every 10.2 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K140713 (Planmeca Oy, 2014) has gone furthest, with 14 descendants of its own.
- 5 other devices also cite its predicate K982422.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 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?
TigerView Professional 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). In addition, TigerView Professional enables the storage of clinical notes, audio recordings, and clinical exam data.
It is intended to acquire, display, edit (e.g., resize, adjust contrast, crop, annotate, etc.), review, store, print, and distribute images using standard PC hardware.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061035 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061035: Tigerview Professional.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061035
Report an extraction error
Are you the manufacturer?
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