510(k) · Cleared
ClearedVivosight Topical Oct System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Michelson Diagnostics, Ltd. · NQQ System, Imaging, Optical Coherence Tomography (Oct)
Cleared on Jan 5, 2010 after a 53-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.
- Decided
- Jan 5, 2010
- Review
- 53 days
- Class
- Class II
- Product code
- NQQ
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 4 citing it directly.
- This deviceK093520 Vivosight Topical Oct SystemMichelson Diagnostics, Ltd. · 2010
- Descendant · cites it directly · 1 of its ownK133209 Foresee (4C) Imaging SystemDiagnostic Photonics, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK242924 OPXION Optical Skin Viewer (OPXSV1-01F)Opxion Technology, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK201552 ApolloVue S100 Image SystemApollo Medical Optics, Ltd. · 2020
- Descendant · 2 generations on · 0 of its ownK191804 TOMi ScopePhotonicare, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK132800 SkintellAgfa Healthcare N.V. · 2014
Most influential descendants
Showing 5 of 5 · See all- K133209Foresee (4C) Imaging SystemDiagnostic Photonics, Inc. · 2014 · cites it directly1descendant
- K242924OPXION Optical Skin Viewer (OPXSV1-01F)Opxion Technology, Inc. · 2025 · cites it directly0descendants
- K201552ApolloVue S100 Image SystemApollo Medical Optics, Ltd. · 2020 · cites it directly0descendants
- K191804TOMi ScopePhotonicare, Inc. · 2019 · 2 generations on0descendants
- K132800SkintellAgfa Healthcare N.V. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K093520 | Vivosight Topical Oct System | Michelson Diagnostics, Ltd. | 2010 | — |
| +1 | K133209 | Foresee (4C) Imaging System | Diagnostic Photonics, Inc. | 2014 | — |
| +1 | K242924 | OPXION Optical Skin Viewer (OPXSV1-01F) | Opxion Technology, Inc. | 2025 | — |
| +1 | K201552 | ApolloVue S100 Image System | Apollo Medical Optics, Ltd. | 2020 | — |
| +2 | K191804 | TOMi Scope | Photonicare, Inc. | 2019 | — |
| +1 | K132800 | Skintell | Agfa Healthcare N.V. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2025 | 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 NQQ? 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 NQQ device
- #1 K251730 LIA Console (542-7)score 16.2 · 20 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 |
|---|---|---|---|
| * | — | Imalux OCT Imaging System Named without a submission number |
What descends from it? (5)
4 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?
- Of its descendants, K133209 (Diagnostic Photonics, Inc., 2014) has gone furthest, with 1 descendant of its own.
How does its category compare?
All NQQ devicesNQQ System, Imaging, Optical Coherence Tomography (Oct): FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · NQQ
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NQQ
146in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NQQ
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NQQ
2in 2025
MAUDE reports naming product code NQQ, 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 | 3 | 82 | 1 | 0 |
| 2011 | 2 | — | 1 | 2 |
| 2012 | 1 | — | 0 | 5 |
| 2013 | 2 | — | 0 | 3 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 5 | 91 | 0 | 3 |
| 2016 | 5 | 91 | 0 | 2 |
| 2017 | 1 | — | 0 | 3 |
| 2018 | 2 | — | 0 | 4 |
| 2019 | 3 | 84 | 0 | 6 |
| 2020 | 2 | — | 0 | 4 |
| 2021 | 2 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 3 | 86 | 0 | 6 |
| 2024 | 2 | — | 0 | 6 |
| 2025 | 8 | 146 | 0 | 2 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
VivoSight is a Multi-Beam Optical Coherence Tomography (OCT) system indicated for use in the two-dimensional, cross-sectional, real-time imaging of external tissues of the human body.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093520 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093520: Vivosight Topical Oct System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093520
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