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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 healthcare providers in skin wound assessment.
Definition A software-aided adjunctive diagnostic device for use by healthcare providers in skin wound assessment uses a software algorithm to analyze optical or other physical properties of a skin wound without direct wound contact and returns characterizing information that may include classification, severity, or healing potential of the skin wound. The device is intended for prescription use by healthcare providers to provide adjunctive information to be used in conjunction with clinical assessment. It is not for use as a standalone diagnostic device.
Product CodeSHY
Regulation Number 878.1840
Device Class 2


Premarket Reviews
ManufacturerDecision
SPECTRALMD, INC.
  GRANTED 1

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