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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 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Manufacturing, Packaging or Shipping Problem 9 9
Nonstandard Device 9 9
Product Quality Problem 9 9

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 9 9

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