De Novo · Granted
GrantedDermaSensor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dermasensor, Inc. · QZS Software-Aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer
Granted on Jan 12, 2024 as a new device type through De Novo after a 344-day review.
- Decided
- Jan 12, 2024
- Review
- 344 days
- Class
- Class II
- Product code
- QZS
- Recalls
- None
De Novo grants create a new device type without a predicate, so this family tree starts here.
Sources: FDA De Novo 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 QZS? 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
Does it have a predicate?
De Novo decisions do not claim a predicate device.
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.
How does its category compare?
All QZS devicesQZS Software-Aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · QZS
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · QZS
Too few QZS 510(k)s in any year since 2007 to give a median.
Recalls per year · QZS
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QZS
2in 2025
MAUDE reports naming product code QZS, 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 | 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 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 1 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The DermaSensor device is indicated for use to evaluate skin lesions suggestive of melanoma, basal cell carcinoma, and/or squamous cell carcinoma in patients aged 40 and above to assist in the decision regarding referral of the patient to a dermatologist. The DermaSensor device should be used in conjunction with the totality of clinically relevant information from the clinical assessment, including visual analysis of the lesion, by physicians who are not dermatologists. The device should be used on lesions already assessed as suspicious for skin cancer and not as a screening tool. The device should not be used as the sole diagnostic criterion nor to confirm clinical diagnosis of skin cancer.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN230008 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN230008: DermaSensor.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN230008
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026