510(k) · Cleared
ClearedClever One
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ewoosoft Co., Ltd. · QIH Automated Radiological Image Processing Software
Cleared on May 23, 2025 as substantially equivalent to K241114 (Ewoosoft Co., Ltd., 2024) and 1 other predicate after a 141-day review. Its family tree reaches back 16 generations to 1993.
- Decided
- May 23, 2025
- Review
- 141 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 16 generations to K930527 (1993). 21 ancestors in all. No later device cites it as a predicate yet.
- Root · 16 generations backK930527 Dental LinkEscan, Inc. · 1993
- 12 generations between
- 3 generations backK222145 EzDent-i / E2 / Prora View/ Smart M ViewerEwoosoft Co., Ltd. · 2022
- 2 generations backK223820 EzDent-i / E2 / Prora View/ Smart M ViewerEwoosoft Co., Ltd. · 2023
- 1 generation backK241114 EzDent-i / E2 / Prora View / Smart M Viewer (v3.5)Ewoosoft Co., Ltd. · 2024
- This deviceK250005 Clever OneEwoosoft Co., Ltd. · 2025
Show all 16 generations
- Root · 16 generations backK930527 Dental LinkEscan, Inc. · 1993
- 15 generations backK955237 Tigerscan/TigerviewTau Corp. · 1996
- 14 generations backK012439 Dentaleye 2 Dental Image Management SystemRadco Data AB · 2002
- 13 generations backK050744 Kavo Ergocom/ErgocamKavo America Corporation · 2005
- 12 generations backK060178 Vix Win ProGendex Dental Systems · 2006 · Recalled
- 11 generations backK131594 Ezdenti-I; E2; Prora ViewEwoosoft Co., Ltd. · 2013
- 10 generations backK150747 EzDent-i /E2/Prora ViewLK Consulting Group USA, Inc. · 2015
- 9 generations backK161117 EzDent-i / E2 / Prora ViewEwoosoft Co., Ltd. · 2016
- 8 generations backK163533 EzDent-i; E2; ProraViewEwoosoft Co., Ltd. · 2017
- 7 generations backK172364 EzDent-i / E2 / Prora ViewEwoosoft Co., Ltd. · 2017
- 6 generations backK190087 EzDent-i / E2 / Prora ViewEwoosoft Co., Ltd. · 2019
- 5 generations backK202116 EzDent-i/ E2/ Prora View/ Smart M ViewerEwoosoft Co., Ltd. · 2020
- 4 generations backK211795 EzDent-i/ E2/ Prora View/ Smart M ViewerEwoosoft Co., Ltd. · 2021
- 3 generations backK222145 EzDent-i / E2 / Prora View/ Smart M ViewerEwoosoft Co., Ltd. · 2022
- 2 generations backK223820 EzDent-i / E2 / Prora View/ Smart M ViewerEwoosoft Co., Ltd. · 2023
- 1 generation backK241114 EzDent-i / E2 / Prora View / Smart M Viewer (v3.5)Ewoosoft Co., Ltd. · 2024
- This deviceK250005 Clever OneEwoosoft Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K930527 | Dental Link | Escan, Inc. | 1993 | — |
| −15 | K955237 | Tigerscan/Tigerview | Tau Corp. | 1996 | — |
| −14 | K012439 | Dentaleye 2 Dental Image Management System | Radco Data AB | 2002 | — |
| −13 | K050744 | Kavo Ergocom/Ergocam | Kavo America Corporation | 2005 | — |
| −12 | K060178 | Vix Win Pro | Gendex Dental Systems | 2006 | 1 |
| −11 | K131594 | Ezdenti-I; E2; Prora View | Ewoosoft Co., Ltd. | 2013 | — |
| −10 | K150747 | EzDent-i /E2/Prora View | LK Consulting Group USA, Inc. | 2015 | — |
| −9 | K161117 | EzDent-i / E2 / Prora View | Ewoosoft Co., Ltd. | 2016 | — |
| −8 | K163533 | EzDent-i; E2; ProraView | Ewoosoft Co., Ltd. | 2017 | — |
| −7 | K172364 | EzDent-i / E2 / Prora View | Ewoosoft Co., Ltd. | 2017 | — |
| −6 | K190087 | EzDent-i / E2 / Prora View | Ewoosoft Co., Ltd. | 2019 | — |
| −5 | K202116 | EzDent-i/ E2/ Prora View/ Smart M Viewer | Ewoosoft Co., Ltd. | 2020 | — |
| −4 | K211795 | EzDent-i/ E2/ Prora View/ Smart M Viewer | Ewoosoft Co., Ltd. | 2021 | — |
| −3 | K222145 | EzDent-i / E2 / Prora View/ Smart M Viewer | Ewoosoft Co., Ltd. | 2022 | — |
| −2 | K223820 | EzDent-i / E2 / Prora View/ Smart M Viewer | Ewoosoft Co., Ltd. | 2023 | — |
| −1 | K241114 | EzDent-i / E2 / Prora View / Smart M Viewer (v3.5) | Ewoosoft Co., Ltd. | 2024 | — |
| 0 (this device) | K250005 | Clever One | Ewoosoft Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 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 QIH? 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 QIH device
- #1 K213998 cvi42 Auto Imaging Software Applicationscore 23.5 · 7 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 |
|---|---|---|---|
| * | K241114 | EzDent-i / E2 / Prora View / Smart M Viewer (v3.5)Summary page 5…lass: Class II • Product Code: QIH 4. Predicate Device: • Manufacturer: Ewoosoft Co., Ltd. • Trade/Device Name: EzDent-i • 510k Number: K241114 • Regulation Number: 21 CFR 892.2050 • Regulation Name: Medical Image Management and Processing System •… | 2024 |
| * | K231757 | Ez3D-i /E3Summary page 5…m • Regulatory Class: Class II • Product Code: LLZ • Manufacturer: Ewoosoft Co., Ltd. • Trade/Device Name: Ez3D-i • 510k Number: K231757 • Regulation Number: 21 CFR 892.2050 • Regulation Name: Automated Radiological Image Processing Software •… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
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 32 years and passes through 7 companies; a new generation was cleared every 1.4 years on median.
- 1 of the 21 ancestors has a recall of any class.
How does its category compare?
All QIH devicesQIH Automated Radiological Image Processing Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · QIH
94in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QIH
150in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QIH
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QIH
4in 2025
MAUDE reports naming product code QIH, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 11 | 145 | 0 | 0 |
| 2021 | 19 | 125 | 0 | 0 |
| 2022 | 25 | 134 | 0 | 0 |
| 2023 | 45 | 151 | 0 | 0 |
| 2024 | 64 | 141 | 0 | 2 |
| 2025 | 94 | 150 | 0 | 4 |
| 2026 | 78 | 130 | 1 | — |
What is it indicated for?
Clever One is dental imaging software that is intended to provide tools for supporting diagnosis and treatment.
These tools enable end users to view and interpret a series of DICOM compliant medical images and are intended for use by trained medical professionals. Clever One allows users to load, view, and save DICOM images from CT, panoramic, cephalometric, intraoral, and other imaging equipment. It also provides functionalities such as 2D viewing, 2D analysis, 3D visualization, 3D analysis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250005 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250005: Clever One.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250005
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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