(28 days)
The Planmed Sophie and Planmed Sophie Classic are mammographic xray systems, which are intended to be used to produce radiographs of the breast. The devices can be equipped with accessories to fulfil different diagnostic needs.
Mammographic X-ray System Planmed Sophie and Sophie Classic Modification
This is an FDA clearance letter for a mammographic X-ray system, not a study report. It states that the device is substantially equivalent to legally marketed predicate devices.
Therefore, the document does not contain the information requested regarding acceptance criteria and the study that proves the device meets those criteria, such as device performance, sample sizes, ground truth establishment, or any details about multi-reader multi-case studies or standalone algorithm performance.
The document primarily focuses on:
- Device: Planmed Sophie and Planmed Sophie Classic Mammographic X-ray Systems (Modification).
- Regulatory Classification: Class II, 21 CFR 892.1710, Procode: 90 IZH.
- Date of Clearance: November 16, 1998.
- Indications for Use: To produce radiographs of the breast.
§ 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.