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CRT2000® Thermographic System – US FDA Approved 510K

By PANACEA/Achievements

Eidam Diagnostics Corporation is a Canadian company headquartered in Richmond, British Columbia with offices in Germany and China. Eidam is the manufacturer and global distributor of its primary product, the CRT 2000® Thermographic System.

The CRT 2000® Thermographic System is an adjunctive diagnostic tool used to complement other procedures in the early detection and prevention of certain illnesses and is intended for use in preventative healthcare. A worldwide network consisting of physicians and healthcare providers use the CRT 2000®. Eidam Diagnostics has recently improved the thermographic system’s functionality and presentation. The CRT 2000® has obtained the CE Mark and since 1998, has been for sale in the United States based upon the device’s US FDA Class I (510k) premarket notification.

The CRT 2000® Thermographic System is a non-invasive, reproducible thermographic tool that evaluates predetermined skin temperature points and is able to detect the changes in the body’s temperature regulation to produce data that can be used for adjunctive diagnosis of certain diseases. The 30 minute CRT examination involves use of a passive skin temperature sensor, or a direct temperature measurement probe, on a patient to take two readings consisting of 119 measurements each.

The CRT 2000® Thermographic System has the following indications for use as an adjunctive diagnostic device under its US FDA 510(k):
• Abnormalities of the female breast
• Peripheral vascular disease
• Musculoskeletal disorders
• Extracranial cerebral and facial vascular disease
• Abnormalities of the thyroid gland
• Various neoplastic and inflammatory conditions