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FDA indications

Spectron IR Medical Infrared Imaging SystemFDA 510(k) Indications for Use

FDA 510(k) #KO32471

Indications for use: The Spectron IR Clinical Infrared Imaging System is intended for adjunctive diagnostic screening for the detection of breast cancer and other uses such as: peripheral vascular disease, neuromusculoskeletal disorders, extracranial cerebral and facial vascular disease, thyroid gland abnormalities, and various other neoplastic, metabolic and inflammatory conditions.


Use of the TyTron C-500 is not intended to be a sole diagnostic procedure for these diseases and conditions.

Click here to view the FDA document.