The AlfaSight 9000TM received 510(K) clearance through the FDA Division of Radiological Health.
INDICATIONS FOR USE
The AlfaSight 9000TM is cleared for marketing and sales in the United States for the adjunct diagnosis of:
Abnormalities of the female breast
Peripheral vascular disease
Extra-cranial cerebral and facial vascular disease
Abnormalities of the thyroid gland
Various neoplastic and inflammatory conditions
The AlfaSight 9000TM 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.
As for Insurance...
We are not involved in any insurance billing, nor reimbursement. However, we do provide a receipt with the information below. We have no relationship with, nor do any communicating nor filing of insurance claims or forms. We have no means of knowing what your policy benefits are, and therefore, make no claims as to whether you will receive any reimbursement for this service. To make it easier for you along with your family physician, we provide the following information:
93740 thermography/temperature gradient study
THERMOGRAPHY CENTER TAX I.D. 02-0534707
Diagnostic ICD-10 Code(s) to be provided by Doctor: R92.8