510(k) · Cleared
ClearedOrthoVision
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ewoosoft Co., Ltd. · LLZ System, Image Processing, Radiological
Cleared on Oct 26, 2017 as substantially equivalent to K131570 (Ewoosoft Co., Ltd., 2013) after a 27-day review. Its family tree reaches back 6 generations to 1993. 18 later devices descend from it.
- Decided
- Oct 26, 2017
- Review
- 27 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K930527 (1993). 7 ancestors in all. 18 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK930527 Dental LinkEscan, Inc. · 1993
- 5 generations backK955237 Tigerscan/TigerviewTau Corp. · 1996
- 4 generations backK012439 Dentaleye 2 Dental Image Management SystemRadco Data AB · 2002
- 3 generations backK043104 Kodak Orthodontic Imaging and Oms Imaging 8.0Practiceworks, Inc. · 2005
- 2 generations backK122427 CS Orthodontic Imaging Software CS Oms Imaging SoftwareCarestream Dental, LLC · 2012
- 1 generation backK131570 OrthovisionEwoosoft Co., Ltd. · 2013
- This deviceK173094 OrthoVisionEwoosoft Co., Ltd. · 2017
- Descendant · cites it directly · 17 of its ownK192888 EzOrthoEwoosoft Co., Ltd. · 2020
- Descendant · 2 generations on · 6 of its ownK210187 Overjet Dental AssistOverjet, Inc. · 2021
- Descendant · 2 generations on · 6 of its ownK202948 EzOrthoEwoosoft Co., Ltd. · 2020
- Descendant · 3 generations on · 5 of its ownK211793 EzOrthoEwoosoft Co., Ltd. · 2021
- Descendant · 4 generations on · 4 of its ownK220003 EzOrtho v1.3Ewoosoft Co., Ltd. · 2022
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K192888EzOrthoEwoosoft Co., Ltd. · 2020 · cites it directly17descendants
- K210187Overjet Dental AssistOverjet, Inc. · 2021 · 2 generations on6descendants
- K202948EzOrthoEwoosoft Co., Ltd. · 2020 · 2 generations on6descendants
- K211793EzOrthoEwoosoft Co., Ltd. · 2021 · 3 generations on5descendants
- K220003EzOrtho v1.3Ewoosoft Co., Ltd. · 2022 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K930527 | Dental Link | Escan, Inc. | 1993 | — |
| −5 | K955237 | Tigerscan/Tigerview | Tau Corp. | 1996 | — |
| −4 | K012439 | Dentaleye 2 Dental Image Management System | Radco Data AB | 2002 | — |
| −3 | K043104 | Kodak Orthodontic Imaging and Oms Imaging 8.0 | Practiceworks, Inc. | 2005 | — |
| −2 | K122427 | CS Orthodontic Imaging Software CS Oms Imaging Software | Carestream Dental, LLC | 2012 | — |
| −1 | K131570 | Orthovision | Ewoosoft Co., Ltd. | 2013 | — |
| 0 (this device) | K173094 | OrthoVision | Ewoosoft Co., Ltd. | 2017 | — |
| +1 | K192888 | EzOrtho | Ewoosoft Co., Ltd. | 2020 | — |
| +2 | K210187 | Overjet Dental Assist | Overjet, Inc. | 2021 | — |
| +2 | K202948 | EzOrtho | Ewoosoft Co., Ltd. | 2020 | — |
| +3 | K211793 | EzOrtho | Ewoosoft Co., Ltd. | 2021 | — |
| +4 | K220003 | EzOrtho v1.3 | Ewoosoft Co., Ltd. | 2022 | — |
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 |
|---|---|---|
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 3 | 0 |
| 2024 | 3 | 0 |
| 2025 | 3 | 0 |
| 2026 | 2 | 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? (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 | Decided |
|---|---|---|---|
| * | K131570 | OrthovisionSummary page 5…of trained and licensed practitioners or dentists. 9. Predicate Device: Manufacturer: EWOOSOFT Co., Ltd. Device: OrthoVision 510(k) Number: K131570 10. Substantial Equivalence: OrthoVision v2.1 described in this 510(k) has the same intended use and the same technical c… | 2013 |
What descends from it? (18)
See all 181 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192888 | EzOrtho | 2020 | 17 |
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 24 years and passes through 6 companies; a new generation was cleared every 4.2 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K192888 (Ewoosoft Co., Ltd., 2020) has gone furthest, with 17 descendants of its own.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
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?
OtrhoVision software is indicated for use by orthodontists for image analysis, simulation, profilogram, growth forecast, VTO/STO and patient consultation. Results produced by the software’s diagnostic, treatment planning and simulation tools are dependent on the interpretation of trained and licensed practitioners or dentists.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173094 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173094: OrthoVision.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173094
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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