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510(k) Data Aggregation
K Number
K183485Device Name
CryoVizion System
Manufacturer
Date Cleared
2019-08-28
(254 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Cryos Technologies Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The CryoVizion is indicated as a tool to quantify angles on digital photograph depictions such as body angles related to postural asymmetries. It is intended for use in professional health specialists such as podiatrists, orthopedist, physiotherapists, chiropractors, osteopaths, and kinesiotherapists
Device Description
The CryoVizion System is a non-invasive and radiation-free system. Patients, suitably undressed, are placed in an observation booth. Two digital colour cameras mounted on a column are placed facing the patient booth. Patients are illuminated by two LED lighting units-one on each side of the imaging column. Using the CryoVizion System, the health specialist can then take images of the patient at various heights and in different positions. These images are then saved in the patient's file. The health specialists can then visually review anatomical and morphological features related to the patient's posture. To do this, the CryoVizion System provides an image analysis toolbox including a palette of six graphic filters. Surface markers corresponding to the anatomical body landmarks placed using palpation by healthcare professionals, prior to taking the photographs, may also be used to help identify and reference anatomical landmarks in the photographs. The CryoVizion System is composed of two sections: hardware and software. The data and the images collected with the CryoVizion System are available immediately for clinical use and may be downloaded to a computer for storage or further analysis or comparison. The hardware section comprises the above noted two digital colour cameras and two LED lighting units, mounted on a column and a positioning booth. The two cameras are mounted in the central tube of the imaging column. The LED lighting systems are vertically disposed to each side of the column. The column also houses the control centre which, linked to a computer, controls the two digital cameras and the intensity of the lighting. The software comprises image manipulation functions, including the user selectable filters noted above and controls to operate each of the cameras.
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