ITM

Introduction

Indications/Intended uses:

In gynecology, the ITM is intended for use as early detection of mammary gland pathologies. There is a possibility to examine teenagers, women of any age, pregnant and breast-feeding women. It allows diagnosis of mastopathy, mastitis, evaluating lactation function as well as monitoring the state of the breasts during mastopathy treatment. In oncology, the ITM is intended for use as an adjunct to mammography in patients who have equivocal mammographic findings within ACR BI-RADSTM categories 3 or 4. In particular, it is not intended for use in cases with clear mammographic or non-mammographic indications for biopsy. This device provides the radiologist with additional information to guide a biopsy recommendation. The device is intended for use on women age > 20 years old. The system will be use by licensed practitioner and the interpretation will be made by radiologists who have satisfactorily completed the training phase of the ITM system.