510(k) · Cleared
ClearedSecond Opinion® Panoramic
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pearl, Inc. · MYN Analyzer, Medical Image
Cleared on Nov 14, 2025 as substantially equivalent to K230144 (Denti.Ai Technology, Inc., 2023) and 1 other predicate after a 266-day review. Its family tree reaches back 10 generations to 1993.
- Decided
- Nov 14, 2025
- Review
- 266 days
- Class
- Class II
- Product code
- MYN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K930527 (1993). 13 ancestors in all. No later device cites it as a predicate yet.
- Root · 10 generations backK930527 Dental LinkEscan, Inc. · 1993
- 6 generations between
- 3 generations backK192888 EzOrthoEwoosoft Co., Ltd. · 2020
- 2 generations backK210187 Overjet Dental AssistOverjet, Inc. · 2021
- 1 generation backK230144 Denti.AI DetectDenti.Ai Technology, Inc. · 2023
- This deviceK250525 Second Opinion® PanoramicPearl, Inc. · 2025
Show all 10 generations
- Root · 10 generations backK930527 Dental LinkEscan, Inc. · 1993
- 9 generations backK955237 Tigerscan/TigerviewTau Corp. · 1996
- 8 generations backK012439 Dentaleye 2 Dental Image Management SystemRadco Data AB · 2002
- 7 generations backK043104 Kodak Orthodontic Imaging and Oms Imaging 8.0Practiceworks, Inc. · 2005
- 6 generations backK122427 CS Orthodontic Imaging Software CS Oms Imaging SoftwareCarestream Dental, LLC · 2012
- 5 generations backK131570 OrthovisionEwoosoft Co., Ltd. · 2013
- 4 generations backK173094 OrthoVisionEwoosoft Co., Ltd. · 2017
- 3 generations backK192888 EzOrthoEwoosoft Co., Ltd. · 2020
- 2 generations backK210187 Overjet Dental AssistOverjet, Inc. · 2021
- 1 generation backK230144 Denti.AI DetectDenti.Ai Technology, Inc. · 2023
- This deviceK250525 Second Opinion® PanoramicPearl, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K930527 | Dental Link | Escan, Inc. | 1993 | — |
| −9 | K955237 | Tigerscan/Tigerview | Tau Corp. | 1996 | — |
| −8 | K012439 | Dentaleye 2 Dental Image Management System | Radco Data AB | 2002 | — |
| −7 | K043104 | Kodak Orthodontic Imaging and Oms Imaging 8.0 | Practiceworks, Inc. | 2005 | — |
| −6 | K122427 | CS Orthodontic Imaging Software CS Oms Imaging Software | Carestream Dental, LLC | 2012 | — |
| −5 | K131570 | Orthovision | Ewoosoft Co., Ltd. | 2013 | — |
| −4 | K173094 | OrthoVision | Ewoosoft Co., Ltd. | 2017 | — |
| −3 | K192888 | EzOrtho | Ewoosoft Co., Ltd. | 2020 | — |
| −2 | K210187 | Overjet Dental Assist | Overjet, Inc. | 2021 | — |
| −1 | K230144 | Denti.AI Detect | Denti.Ai Technology, Inc. | 2023 | — |
| 0 (this device) | K250525 | Second Opinion® Panoramic | Pearl, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 2022 | 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 MYN? 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 MYN device
- #1 K210365 Second Opinionscore 29.9 · 1 generation · 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 |
|---|---|---|---|
| * | K230144 | Denti.AI DetectSummary page 5…ormation Primary Predicate Device: The primary proposed predicate device for clearance of Second Opinion® PR is Denti.AI Detect by Denti.AI Technology, Inc., cleared in (K230144, October 6, 2023), an automated software device classified as a Class II device pursuant to 21 CFR §892.2070, under product code… | 2023 |
| * | K210365 | Second OpinionSummary page 6…lucencies in panoramic radiographs. Secondary Predicate Device: The proposed secondary predicate is the Second Opinion® device, by Pearl Inc., cleared on March 04, 2022 (K210365) and classified as a Class II Medical Image Analyzer pursuant to 21 CFR §892.2070, under product code MYN (Analyzer, Medical Imag… | 2022 |
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 9 companies; a new generation was cleared every 2.8 years on median.
- 1 of the 13 ancestors has a recall of any class.
How does its category compare?
All MYN devicesMYN Analyzer, Medical Image: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · MYN
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MYN
210in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MYN
No recall names MYN since 2007.
Adverse event reports per year · MYN
2in 2025
MAUDE reports naming product code MYN, 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 | 5 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 6 | — | 0 | 0 |
| 2013 | 4 | — | 0 | 0 |
| 2014 | 3 | — | 0 | 0 |
| 2015 | 3 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 3 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 5 | 273 | 0 | 0 |
| 2023 | 10 | 229 | 0 | 0 |
| 2024 | 2 | — | 0 | 1 |
| 2025 | 14 | 210 | 0 | 2 |
| 2026 | 7 | 128 | 0 | — |
What is it indicated for?
Second Opinion® Panoramic is a radiological automated image processing software device intended to identify and mark regions, in panoramic radiographs, in relation to suspected dental findings which include: Caries, Periapical radiolucency, and Impacted third molars.
It is designed to aid dental health professionals to review panoramic radiographs of permanent teeth in patients 16 years of age or older as both a concurrent and second reader.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250525 · printed Nov 5, 2026
Cite this page
510(k) Report. “K250525: Second Opinion® Panoramic.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K250525
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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