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510(k) Data Aggregation
K Number
K230734Device Name
Multispectral Imager Kit (MSI Kit) (300-00015), Multispectral Imager (MSI) (300-00009)
Manufacturer
Precision Healing LLC
Date Cleared
2023-12-05
(264 days)
Product Code
QJF, FXN, OCR
Regulation Number
878.4550Why did this record match?
Applicant Name (Manufacturer) :
Precision Healing LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MSI is a handheld imaging tool that allows clinicians diagnosing and treating skin wounds to:
· View and digitally record images of a wound.
· Measure and digitally record the size of a wound.
- · View and digitally record images of fluorescence emitted from a wound when exposed to an excitation light.
· View and digitally record thermal images of a wound.
The MSI does not diagnose or treat skin wounds.
Device Description
The MSI Kit includes the following: the MSI, a Universal Serial Bus (USB-C) cable, a wall adapter, and a carrying case.
The MSI captures and processes optical data of an imaged wound. The MSI consists of three imaging modalities: white light, autofluorescence and thermal. The MSI has 395nm excitation LEDs for autofluorescence imaging, a sensor for measuring distance to the wound, and a thermal sensor for capturing temperature gradients.
The MSI is powered by an onboard rechargeable battery and has a USB-C connection for uploading images to a computer. The manual provides users of the MSI with detailed instructions for proper use, maintenance, and storage.
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