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510(k) Data Aggregation
K Number
K023434Device Name
DOREX SPECTRUM 9000MB THERMOGRAPHY SYSTEM
Manufacturer
DOREX, INC.
Date Cleared
2002-11-14
(30 days)
Product Code
LHQ
Regulation Number
884.2980Why did this record match?
Applicant Name (Manufacturer) :
DOREX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Thermal Imaging is a noninvasive diagnostic technique that allows a practitioner to quantify and visualize skin surface temperature changes. The Spectrum 9000 MB allows the user to graphically map the body temperature and display the image on a monitor. The Spectrum 9000MB will be used as an aid for diagnosis as well as to follow up therapy on such areas as orthopedics, pain management, neurology and diabetic foot care.
The intended use for the Spectrum 9000 MB is similar to what is being used currently on the Dorex DTI-16 thermal imager. Images are captured and stored on a computer that can be used to diagnose problem areas.
Device Description
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