(87 days)
To provide a platform to conduct minimally invasive breast biopsy procedures.
A biopsy system, which uses x-ray guidance for stereotactic localization, that allows the physician to accurately place a biopsy needle for the retrieval of tissue samples in the area of concern. The tissue removed will require further evaluation through pathological assessment.
The system, in combination with the Kuske Breast Applicator Set and the Comfort Catheter System, can also be used as a table platform to perform Interstitial Brachytherapy procedures. The Kuske Breast Applicator Set and the Comfort Catheter System are stand alone items that do not attach to the system. The table platform is utilized as a means to image the area of interest and to image the template for placement of the catheters.
Not Found
I am sorry, but the provided text is a 510(k) clearance letter for the MammoTest® device and not a study report. It does not contain the detailed information about acceptance criteria and study results you requested. Therefore, I cannot generate the specific table and answer the questions based on the input.
The document primarily states that the FDA has reviewed the device and found it substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It also lists the indications for use of the MammoTest® system.
§ 892.1710 Mammographic x-ray system.
(a)
Identification. A mammographic x-ray system is a device intended to be used to produce radiographs of the breast. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.