510(k) · Cleared
ClearedVIO System (V-1000)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Enspectra Health, Inc. · QZN Multi-Photon Imaging
Cleared on Dec 22, 2023 as substantially equivalent to K180162 (Caliber Imaging & Diagnostics, Inc., 2018) after a 102-day review. Its family tree reaches back 1 generation to 2018.
- Decided
- Dec 22, 2023
- Review
- 102 days
- Class
- Class II
- Product code
- QZN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K180162 (2018). No later device cites it as a predicate yet.
- Root · 1 generation backK180162 VivaScope SystemCaliber Imaging & Diagnostics, Inc. · 2018
- This deviceK232789 VIO System (V-1000)Enspectra Health, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K180162 | VivaScope System | Caliber Imaging & Diagnostics, Inc. | 2018 | — |
| 0 (this device) | K232789 | VIO System (V-1000) | Enspectra Health, Inc. | 2023 | — |
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 QZN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K180162 | VivaScope SystemSummary page 5…gical Lamp Class: II Product Code: QZN: Multi-photon imaging C. PREDICATE DEVICE VivaScope System (Caliber Imaging & Diagnostics, K180162) This predicate device has not been subject to a design related recall. No reference devices were used in this subm… | 2018 |
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.
How does its category compare?
All QZN devicesQZN Multi-Photon Imaging: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QZN
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · QZN
Too few QZN 510(k)s in any year since 2007 to give a median.
Recalls per year · QZN
No recall names QZN since 2007.
Adverse event reports per year · QZN
No MAUDE report names QZN since 2007.
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 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The VIO System is intended to acquire, store, retrieve, display and transfer in vivo images of tissue – including blood vessels, collagen, pigment, stratum corneum, hair shafts or follicles, solar elastosis, hyperkeratosis, atypia, and epidermal disarray – in and through epidermis for review by physicians to assist in forming a clinical judgment. Physicians who interpret VIO System images must have dermatology or pathology medical qualifications with skin histology assessment training.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232789 · printed Nov 5, 2026
Cite this page
510(k) Report. “K232789: VIO System (V-1000).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K232789
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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