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ITM

>Indications / Intended uses
In Gynecology:
The ITM is intended for use as early detection of mammary gland pathologies 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.

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