510(k) · Cleared
ClearedVELMENI for DENTISTS (V4D) 3D
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Velmeni, Inc. · QIH Automated Radiological Image Processing Software
Cleared on Jul 23, 2026 as substantially equivalent to K243989 (Pearl, Inc., 2025) after a 216-day review. Its family tree reaches back 13 generations to 1996.
- Decided
- Jul 23, 2026
- Review
- 216 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K954678 (1996). 30 ancestors in all, the oldest K924810 (1993). No later device cites it as a predicate yet.
- Root · 13 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 9 generations between
- 3 generations backK213562 DTX Studio Clinic 3.0Nobel Biocare AB · 2022
- 2 generations backK233925 Relu CreatorRelu BV · 2024
- 1 generation backK243989 Second Opinion® 3DPearl, Inc. · 2025
- This deviceK254096 VELMENI for DENTISTS (V4D) 3DVelmeni, Inc. · 2026
Show all 13 generations
- Root · 13 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 12 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 11 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 10 generations backK013878 Cybermed, Inc., V-WorksCybermed, Inc. · 2001
- 9 generations backK053155 VimplantCybermed, Inc. · 2005
- 8 generations backK070803 InvivodentalAnatomage, Inc. · 2007
- 7 generations backK123519 Invivo DentalAnatomage, Inc. · 2013
- 6 generations backK140713 Planmeca RomexisPlanmeca Oy · 2014
- 5 generations backK162799 CliniviewPalodex Group OY · 2017
- 4 generations backK203156 DTX Studio ClinicNobel Biocare AB · 2020
- 3 generations backK213562 DTX Studio Clinic 3.0Nobel Biocare AB · 2022
- 2 generations backK233925 Relu CreatorRelu BV · 2024
- 1 generation backK243989 Second Opinion® 3DPearl, Inc. · 2025
- This deviceK254096 VELMENI for DENTISTS (V4D) 3DVelmeni, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −12 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −11 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −10 | K013878 | Cybermed, Inc., V-Works | Cybermed, Inc. | 2001 | — |
| −9 | K053155 | Vimplant | Cybermed, Inc. | 2005 | — |
| −8 | K070803 | Invivodental | Anatomage, Inc. | 2007 | — |
| −7 | K123519 | Invivo Dental | Anatomage, Inc. | 2013 | — |
| −6 | K140713 | Planmeca Romexis | Planmeca Oy | 2014 | — |
| −5 | K162799 | Cliniview | Palodex Group OY | 2017 | — |
| −4 | K203156 | DTX Studio Clinic | Nobel Biocare AB | 2020 | — |
| −3 | K213562 | DTX Studio Clinic 3.0 | Nobel Biocare AB | 2022 | — |
| −2 | K233925 | Relu Creator | Relu BV | 2024 | — |
| −1 | K243989 | Second Opinion® 3D | Pearl, Inc. | 2025 | — |
| 0 (this device) | K254096 | VELMENI for DENTISTS (V4D) 3D | Velmeni, Inc. | 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 |
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 23.6 · 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 |
|---|---|---|---|
| * | K243989 | Second Opinion® 3DSummary page 5…21 CFR 892.2050 Product Code: QIH Device Class: Class II Predicate Device Predicate Device: Pearl Second Opinion 3D (K243989) Device Description V4D 3D introduces 3D image processing to the VELMENI AI platform. The device comprises of the following ke… | 2025 |
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 30 years and passes through 10 companies; a new generation was cleared every 2.1 years on median.
- 2 of the 30 ancestors have a recall of any class.
- 1 other device also cites its predicate K243989.
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. 2026, 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?
VELMENI for DENTISTS (V4D) 3D is radiological, automated, concurrent read, computer-assisted detection software intended to assist in the clinical detection of anatomical structures (maxilla plus cranium, mandible, mandibular canal, temporomandibular joint, maxillary sinus ,teeth ,airway) in CBCT radiographs of permanent teeth in patients 15 years of age or older. This device provides additional information for licensed dental professionals in examining…
Read the full statement (111 words)
VELMENI for DENTISTS (V4D) 3D is radiological, automated, concurrent read, computer-assisted detection software intended to assist in the clinical detection of anatomical structures (maxilla plus cranium, mandible, mandibular canal, temporomandibular joint, maxillary sinus ,teeth ,airway) in CBCT radiographs of permanent teeth in patients 15 years of age or older. This device provides additional information for licensed dental professionals in examining radiographs of patients' teeth. The device is not intended as a substitute for a complete examination by the dental professional or their clinical judgment that considers other relevant information from the patient's history or actual in-vivo clinical assessment. Final diagnoses and patient treatment plan are the responsibility of the dental professional.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K254096 · printed Nov 4, 2026
Cite this page
510(k) Report. “K254096: VELMENI for DENTISTS (V4D) 3D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K254096
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026