510(k) · Cleared
ClearedSecond Opinion® 3D
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pearl, Inc. · QIH Automated Radiological Image Processing Software
Cleared on May 23, 2025 as substantially equivalent to K233925 (Relu BV, 2024) after a 148-day review. Its family tree reaches back 12 generations to 1996. 3 later devices descend from it.
- Decided
- May 23, 2025
- Review
- 148 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K954678 (1996). 29 ancestors in all, the oldest K924810 (1993). 3 later devices descend from it, 2 citing it directly.
- Root · 12 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 8 generations between
- 3 generations backK203156 DTX Studio ClinicNobel Biocare AB · 2020
- 2 generations backK213562 DTX Studio Clinic 3.0Nobel Biocare AB · 2022
- 1 generation backK233925 Relu CreatorRelu BV · 2024
- This deviceK243989 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 · cites it directly · 0 of its ownK254096 VELMENI for DENTISTS (V4D) 3DVelmeni, Inc. · 2026
Show all 12 generations
- Root · 12 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 11 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 10 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 9 generations backK013878 Cybermed, Inc., V-WorksCybermed, Inc. · 2001
- 8 generations backK053155 VimplantCybermed, Inc. · 2005
- 7 generations backK070803 InvivodentalAnatomage, Inc. · 2007
- 6 generations backK123519 Invivo DentalAnatomage, Inc. · 2013
- 5 generations backK140713 Planmeca RomexisPlanmeca Oy · 2014
- 4 generations backK162799 CliniviewPalodex Group OY · 2017
- 3 generations backK203156 DTX Studio ClinicNobel Biocare AB · 2020
- 2 generations backK213562 DTX Studio Clinic 3.0Nobel Biocare AB · 2022
- 1 generation backK233925 Relu CreatorRelu BV · 2024
- This deviceK243989 Second Opinion® 3DPearl, Inc. · 2025
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −11 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −10 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −9 | K013878 | Cybermed, Inc., V-Works | Cybermed, Inc. | 2001 | — |
| −8 | K053155 | Vimplant | Cybermed, Inc. | 2005 | — |
| −7 | K070803 | Invivodental | Anatomage, Inc. | 2007 | — |
| −6 | K123519 | Invivo Dental | Anatomage, Inc. | 2013 | — |
| −5 | K140713 | Planmeca Romexis | Planmeca Oy | 2014 | — |
| −4 | K162799 | Cliniview | Palodex Group OY | 2017 | — |
| −3 | K203156 | DTX Studio Clinic | Nobel Biocare AB | 2020 | — |
| −2 | K213562 | DTX Studio Clinic 3.0 | Nobel Biocare AB | 2022 | — |
| −1 | K233925 | Relu Creator | Relu BV | 2024 | — |
| 0 (this device) | 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 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K233925 | Relu CreatorSummary page 5…mage Processing System) 5. Predicate Information Predicate device: proposed predicate device for clearance of Second Opinion® 3D is Relu Creator by Relu BV, cleared in (K233925, June 13, 2024), a semi-automated software device classified as a Class II device pursuant to 21 CFR §892.2050 Medical image mana… | 2024 |
What descends from it? (3)
2 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 29 years and passes through 9 companies; a new generation was cleared every 2.2 years on median.
- 2 of the 29 ancestors have a recall of any class.
- Of its descendants, K260785 (Dentsply Sirona, 2026) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K233925.
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?
Second Opinion® 3D is a radiological automated image processing software device intended to identify and mark clinically relevant anatomy in dental CBCT radiographs; specifically Dentition, Maxilla, Mandible, Inferior Alveolar Canal and Mental Foramen (IAN), Maxillary Sinus, Nasal space, and airway. It should not be used in lieu of full patient evaluation or solely relied upon to make or confirm a diagnosis.
It is designed to aid health professionals to review CBCT radiographs of patients 12 years of age or older as a concurrent and second reader
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243989 · printed Nov 5, 2026
Cite this page
510(k) Report. “K243989: Second Opinion® 3D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K243989
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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