510(k) · Cleared
ClearedSecond Opinion CC
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 Jan 16, 2025 as substantially equivalent to K210365 (Pearl, Inc., 2022) and 1 other predicate after a 146-day review. Its family tree reaches back 3 generations to 1998.
- Decided
- Jan 16, 2025
- Review
- 146 days
- Class
- Class II
- Product code
- MYN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to P980025 (1998). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | P980025 | Logicon Caries Detector | Carestream Dental, LLC | 1998 | 1 |
| −2 | K212519 | Overjet Caries Assist | Overjet, Inc. | 2022 | — |
| −1 | K222746 | Overjet Caries Assist | Overjet, Inc. | 2023 | — |
| 0 (this device) | K242522 | Second Opinion CC | Pearl, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K210365 | Second OpinionSummary page 5…dicate Information Predicate device: The proposed primary predicate device is the first clearance of the Second Opinion device, by Pearl Inc., cleared on March 04, 2022 (K210365) classified as a Class II Medical Image Analyzer pursuant to 21 CFR §892.2070, under product code MYN (Analyzer, Medical Image).… | 2022 |
| * | K222746 | Overjet Caries AssistSummary page 6…uses polygons instead of boxes to mark the detection. The proposed secondary predicate device is Overjet Dental Caries Assist by Overjet Inc., cleared on March 27, 2023 (K222746) under product code MYN. The Overjet Dental Carries Assist has the same technology (AI software) and intended use as CADe to aid… | 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 27 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 8 other devices also cite its predicate K210365.
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® CC is a computer aided detection ("CADe”) software to aid dentists in the detection of caries by drawing bounding polygons to highlight the suspected region of interest.
It is designed to aid dental health professionals to review bitewing and periapical radiographs of permanent teeth in patients 19 years of age or older as a second reader.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242522 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242522: Second Opinion CC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242522
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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