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510(k) Data Aggregation
K Number
K190074Device Name
Presero 3D Scanning System
Manufacturer
Date Cleared
2019-02-14
(29 days)
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Certis Health
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Presero 3D Scanning System is an imaging tool that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a 3D imaging device. It is indicated for the use of capturing visual images to measure the diameter, surface area, perimeter and volume of wounds. The Presero 3D Scanning System is designed for use by health care professionals and is intended to assist the healthcare professional who is responsible for making all final patient management decisions.
Device Description
The Presero 3D Scanning System is a tablet-based system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a 3D imaging device. The Presero 3D Scanning System, does not contact the patient, nor does it control any life sustaining devices. A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed. The Presero 3D Scanning System is comprised of a commercial off the shelf 3D camera fitted on a commercial off the shelf tablet, equipped with a proprietary software application that enables a health care professional to visualize and interact with 3D wound images, via a pen-like stylus, to assist in clinical decision making. The complete system (tablet, camera and software) integrates with a cloud back-end system. The cloud back-end system stores all patient data, operator details and other information allowing 2-way synchronization between the Presero 3D Scanning System and the cloud with the ability to fully support multiple systems within a single clinical facility.
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