The AlfaSightTM 9000 received 510(K) clearance through the FDA Division of Radiological Health.
Indications for Use
The AlfaSightTM9000 is cleared for marketing and sales in the United States for the adjunct diagnosis of:
- abnormalities of the female breast
- peripheral vascular disease
- musculoskeletal disorders
- extra-cranial cerebral and facial vascular disease
- abnormalities of the thyroid gland
- various neoplastic and inflammatory conditions
The AlfaSightTM9000 is not intended to serve as a sole diagnostic screening procedure. It is intended as an adjunct diagnostic device only. Thermometry is not a replacement for Mammography or any other imaging method, rather it is to be used in conjunction with conventional testing to provide a physiological perspective.