510(k) · Cleared
ClearedRelu Creator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Relu BV · QIH Automated Radiological Image Processing Software
Cleared on Jun 13, 2024 as substantially equivalent to K213562 (Nobel Biocare AB, 2022) after a 183-day review. Its family tree reaches back 11 generations to 1996. 6 later devices descend from it.
- Decided
- Jun 13, 2024
- Review
- 183 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K954678 (1996). 28 ancestors in all, the oldest K924810 (1993). 6 later devices descend from it, 4 citing it directly.
- Root · 11 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 7 generations between
- 3 generations backK162799 CliniviewPalodex Group OY · 2017
- 2 generations backK203156 DTX Studio ClinicNobel Biocare AB · 2020
- 1 generation backK213562 DTX Studio Clinic 3.0Nobel Biocare AB · 2022
- This deviceK233925 Relu CreatorRelu BV · 2024
- Descendant · cites it directly · 3 of its ownK243989 Second Opinion® 3DPearl, Inc. · 2025
- Descendant · cites it directly · 1 of its ownK260785 DS Core CBCT AnatomyDentsply Sirona · 2026
- Descendant · 2 generations on · 0 of its ownK262127 DS Core CBCT AnatomyDentsply Sirona · 2026
- Descendant · 2 generations on · 0 of its ownK254096 VELMENI for DENTISTS (V4D) 3DVelmeni, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK252538 CEPHX3DOrca Dental AI, Ltd. · 2026
Show all 11 generations
- Root · 11 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 10 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 9 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 8 generations backK013878 Cybermed, Inc., V-WorksCybermed, Inc. · 2001
- 7 generations backK053155 VimplantCybermed, Inc. · 2005
- 6 generations backK070803 InvivodentalAnatomage, Inc. · 2007
- 5 generations backK123519 Invivo DentalAnatomage, Inc. · 2013
- 4 generations backK140713 Planmeca RomexisPlanmeca Oy · 2014
- 3 generations backK162799 CliniviewPalodex Group OY · 2017
- 2 generations backK203156 DTX Studio ClinicNobel Biocare AB · 2020
- 1 generation backK213562 DTX Studio Clinic 3.0Nobel Biocare AB · 2022
- This deviceK233925 Relu CreatorRelu BV · 2024
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K243989Second Opinion® 3DPearl, Inc. · 2025 · cites it directly3descendants
- K260785DS Core CBCT AnatomyDentsply Sirona · 2026 · cites it directly1descendant
- K262127DS Core CBCT AnatomyDentsply Sirona · 2026 · 2 generations on0descendants
- K254096VELMENI for DENTISTS (V4D) 3DVelmeni, Inc. · 2026 · 2 generations on0descendants
- K252538CEPHX3DOrca Dental AI, Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −10 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −9 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −8 | K013878 | Cybermed, Inc., V-Works | Cybermed, Inc. | 2001 | — |
| −7 | K053155 | Vimplant | Cybermed, Inc. | 2005 | — |
| −6 | K070803 | Invivodental | Anatomage, Inc. | 2007 | — |
| −5 | K123519 | Invivo Dental | Anatomage, Inc. | 2013 | — |
| −4 | K140713 | Planmeca Romexis | Planmeca Oy | 2014 | — |
| −3 | K162799 | Cliniview | Palodex Group OY | 2017 | — |
| −2 | K203156 | DTX Studio Clinic | Nobel Biocare AB | 2020 | — |
| −1 | K213562 | DTX Studio Clinic 3.0 | Nobel Biocare AB | 2022 | — |
| 0 (this device) | K233925 | Relu Creator | Relu BV | 2024 | — |
| +1 | K243989 | Second Opinion® 3D | Pearl, Inc. | 2025 | — |
| +1 | K260785 | DS Core CBCT Anatomy | Dentsply Sirona | 2026 | — |
| +2 | K262127 | DS Core CBCT Anatomy | Dentsply Sirona | 2026 | — |
| +2 | K254096 | VELMENI for DENTISTS (V4D) 3D | Velmeni, Inc. | 2026 | — |
| +1 | K252538 | CEPHX3D | Orca Dental AI, Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 4 | 0 |
| 2008 | 1 | 0 |
| 2014 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 2 | 0 |
| 2026 | 4 | 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? (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 |
|---|---|---|---|
| * | K213562 | DTX Studio Clinic 3.0Summary page 4…21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K213562 DTX Studio Clinic 3.0 ILL Device Description S… | 2022 |
What descends from it? (6)
4 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 28 years and passes through 8 companies; a new generation was cleared every 2.2 years on median.
- 2 of the 28 ancestors have a recall of any class.
- Of its descendants, K243989 (Pearl, Inc., 2025) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K213562.
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. 2024, 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?
Relu Creator is a software program for the management, transfer, and analysis of dental and craniomaxillofacial image information, and can be used to provide design input for dental solutions. It displays and enhances digital images from various sources to support the diagnostic process and treatment planning. It stores and provides these images within the system or across computer systems at different locations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233925 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233925: Relu Creator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233925
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