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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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.
Product CodeQZS
Regulation Number 878.1830
Device Class 2


Premarket Reviews
ManufacturerDecision
DERMASENSOR, INC.
  GRANTED 1

MDR Year MDR Reports MDR Events
2025 2 2
2026 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Manufacturing, Packaging or Shipping Problem 11 11
Product Quality Problem 11 11
Nonstandard Device 11 11

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 11 11

Recalls
Manufacturer Recall Class Date Posted
1 DERMASENSOR INC II Nov-21-2025
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