FDA product code QZS: Software-Aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer
QZS is the FDA product code for software-aided adjunctive diagnostic device for use by physicians on lesions suspicious for skin cancer. It is a Class II device, regulated under 21 CFR 878.1830 and reviewed by the General and Plastic Surgery panel. Devices under QZS reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it. FDA has posted 1 recall for QZS devices, 1 initiated in the last five years.
Definition
A software-aided adjunctive diagnostic device for use by physicians on lesions suspicious for skin cancer is a prescription device that uses a software algorithm to analyze optical or other physical properties of a skin lesion and returns a classification of the skin lesion. The device is intended for use by a physician not trained in the clinical diagnosis and management of skin cancer as an adjunctive second-read device following identification of a suspicious skin lesion. It is not for use as a standalone diagnostic and is not for use to confirm a clinical diagnosis.
Classification
| Field | Value |
|---|---|
| Device name | Software-Aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer |
| Device class | Class II |
| Regulation | 21 CFR 878.1830 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
Recalls for QZS devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-10-13.
| Year | Recalls |
|---|---|
| 2025 | 1 |
Frequently asked questions
What is FDA product code QZS?
QZS is the FDA product code for software-aided adjunctive diagnostic device for use by physicians on lesions suspicious for skin cancer. It is a Class II device, regulated under 21 CFR 878.1830 and reviewed by the General and Plastic Surgery panel.
What device class is QZS?
Class II, regulation 21 CFR 878.1830. Typical premarket route: 510(k).
Have QZS devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2025-10-13.
Next steps
- Run an FDA pathway report with predicate devices for product code QZS
- Run a recall and safety report across every QZS manufacturer
- Watch product code QZS for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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