| Device |
software-aided adjunctive diagnostic device for use by physicians on lesions suspicious for skin cancer |
| 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. |
| Physical State |
Optical Device |
| Technical Method |
Hardware and software are used to capture an optical signal that is then analyzed by an artificial intelligence/machine learning (AI/ML) software algorithm to deliver adjunctive diagnostic information to a clinician |
| Target Area |
Skin Lesion |
| Regulation Medical Specialty |
General & Plastic Surgery |
| Review Panel |
General & Plastic Surgery |
|---|
| Product Code | QZS |
|---|
| Premarket Review |
General Surgery Devices
(DHT4A)
General Surgery Devices
(DHT4A)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
878.1830
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
