510(k) · Cleared
ClearedOPXION Optical Skin Viewer (OPXSV1-01F)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Opxion Technology, Inc. · NQQ System, Imaging, Optical Coherence Tomography (Oct)
Cleared on Jun 23, 2025 as substantially equivalent to K093520 (Michelson Diagnostics, Ltd., 2010) after a 272-day review. Its family tree reaches back 1 generation to 2010.
- Decided
- Jun 23, 2025
- Review
- 272 days
- Class
- Class II
- Product code
- NQQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K093520 (2010). No later device cites it as a predicate yet.
- Root · 1 generation backK093520 Vivosight Topical Oct SystemMichelson Diagnostics, Ltd. · 2010
- This deviceK242924 OPXION Optical Skin Viewer (OPXSV1-01F)Opxion Technology, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K093520 | Vivosight Topical Oct System | Michelson Diagnostics, Ltd. | 2010 | — |
| 0 (this device) | K242924 | OPXION Optical Skin Viewer (OPXSV1-01F) | Opxion Technology, Inc. | 2025 | — |
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 |
|---|---|---|---|
| * | K093520 | Vivosight Topical Oct SystemSummary page 6…Regulation Name: Ultrasonic pulsed echo imaging system 510(k) Number: K093520 510(k) Submitter: Michelson Diagnostics Ltd Device Class: Class I… | 2010 |
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?
- Its one ancestor has no recall.
- 3 other devices also cite its predicate K093520.
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. 2025, 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?
OPXION Optical Skin Viewer is a non-invasive imaging system intended to be used for real-time visualization of the external tissues of the human body. The two-dimensional, cross-sectional, three-dimensional, and en-face images of tissue microstructures can be obtained.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242924 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242924: OPXION Optical Skin Viewer (OPXSV1-01F).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242924
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