510(k) · Cleared
ClearedVidea Caries Assist
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Videahealth, Inc. · MYN Analyzer, Medical Image
Cleared on Apr 21, 2022 as substantially equivalent to P980025 (Carestream Dental, LLC, 1998) after a 136-day review. Its family tree reaches back 1 generation to 1998. 9 later devices descend from it.
- Decided
- Apr 21, 2022
- Review
- 136 days
- Class
- Class II
- Product code
- MYN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to P980025 (1998). 9 later devices descend from it, 2 citing it directly.
- Root · 1 generation backP980025 Logicon Caries DetectorCarestream Dental, LLC · 1998 · Recalled
- This deviceK213795 Videa Caries AssistVideahealth, Inc. · 2022
- Descendant · cites it directly · 5 of its ownK221921 DTX Studio Clinic 3.0Nobel Biocare AB · 2023
- Descendant · cites it directly · 2 of its ownK232384 Videa Dental AssistVideahealth, Inc. · 2023
- Descendant · 2 generations on · 2 of its ownK231678 Overjet Periapical Radiolucency AssistOverjet, Inc. · 2023
- Descendant · 2 generations on · 1 of its ownK231898 DTX Studio Clinic (4.0)Nobel Biocare AB · 2023
- Descendant · 3 generations on · 0 of its ownK252934 DiagnocatDgnct, LLC · 2026
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K221921DTX Studio Clinic 3.0Nobel Biocare AB · 2023 · cites it directly5descendants
- K232384Videa Dental AssistVideahealth, Inc. · 2023 · cites it directly2descendants
- K231678Overjet Periapical Radiolucency AssistOverjet, Inc. · 2023 · 2 generations on2descendants
- K231898DTX Studio Clinic (4.0)Nobel Biocare AB · 2023 · 2 generations on1descendant
- K252934DiagnocatDgnct, LLC · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | P980025 | Logicon Caries Detector | Carestream Dental, LLC | 1998 | 1 |
| 0 (this device) | K213795 | Videa Caries Assist | Videahealth, Inc. | 2022 | — |
| +1 | K221921 | DTX Studio Clinic 3.0 | Nobel Biocare AB | 2023 | — |
| +1 | K232384 | Videa Dental Assist | Videahealth, Inc. | 2023 | — |
| +2 | K231678 | Overjet Periapical Radiolucency Assist | Overjet, Inc. | 2023 | — |
| +2 | K231898 | DTX Studio Clinic (4.0) | Nobel Biocare AB | 2023 | — |
| +3 | K252934 | Diagnocat | Dgnct, LLC | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 4 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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 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? (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 |
|---|---|---|---|
| * | P980025 | Logicon Caries DetectorSummary page 4…n Name 21 CFR 892.2070 Analyzer, Medical Image Regulatory Class: 2 Product Code: MYN 3. PREDICATE DEVICE Predicate Device: P980025 Logicon Caries Detection Software (Carestream Dental LLC) 510(k) Summary – K213795… | 1998 |
What descends from it? (9)
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?
How does its category compare?
All MYN devicesMYN Analyzer, Medical Image: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
Videa Caries Assist is a computer-assisted detection (CADe) device that analyzes intraoral radiographs to identify and
localize carious lesions. Videa Caries Assist is indicated for use by board licensed dentists for the concurrent review of
bitewing (BW) radiographs acquired from adult patients aged 22 years or older.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K213795 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213795: Videa Caries Assist.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213795
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