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510(k) Data Aggregation
K Number
K131596Device Name
WOUND MEASURING & MONITORING DEVICE
Manufacturer
WOUNDVISION, LLC
Date Cleared
2013-12-11
(191 days)
Product Code
FXN
Regulation Number
878.4160Why did this record match?
Applicant Name (Manufacturer) :
WOUNDVISION, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Scout is a combination digital camera and long-wave infrared camera. The digital camera is indicated for the use of capturing visual images to measure the diameter, surface area, and perimeter of a part of the body or two body surfaces. The long-wave infrared camera is indicated for the use of capturing thermal images to measure the thermal intensity data of a part of the body or two body surfaces. Both components of the Scout are non-contact with respect to the patient and provide an adjunctive tool to help a trained and qualified health care professional measure and record external wound and body surface data.
Intended for qualified healthcare professionals who are trained in its use, the Scout is a non-invasive and non-radiating device.
The Scout is to be used on a patient population that includes non-pregnant female or male patients 18 years of age or older. The Scout is intended to be used in hospital, acute and sub-acute care settings, long term care, surgery, health care practitioner facilities, outpatient, home healthcare, or in any environment where health care is provided by a qualified health care professional.
The Scout does not provide a diagnosis or therapy.
Device Description
The Scout is a combination digital camera and long-wave infrared camera. The clinician simultaneously captures a visual and infrared image that can be uploaded and stored with a patient's electronic medical record. Body surface size and thermal intensity data can be measured and recorded.
The digital camera captures the visible light wavelengths from the electromagnetic spectrum that is visible to the human eye. The infrared camera captures the infrared radiation emitted by the human body from the electromagnetic spectrum that is not visible to the human eye.
Both cameras are housed in a plastic casing which transmits captured data to a PC.
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