(71 days)
The Planmed Sophie and Planmed Sophie Classic are Mammographic X-ray Systems, which are intended to be used to produce radiographs of the human breast. The devices can be equipped with accessories to fulfil different diagnostic needs.
Mammographic X-ray Systems
The provided text is a 510(k) FDA clearance letter for the "Planmed Sophie & Planmed Sophie Classic" mammographic x-ray systems. This document does not contain any information regarding acceptance criteria, device performance studies, or details about AI algorithms.
The letter primarily focuses on:
- Confirming that the device has been reviewed and determined to be substantially equivalent to legally marketed predicate devices.
- Outlining the regulatory class and product code.
- Advising the manufacturer on their responsibilities under the Federal Food, Drug, and Cosmetic Act, including general controls, registration, listing, good manufacturing practices, and labeling.
- Enclosing the "Indications For Use" statement for the device.
Therefore, I cannot extract the requested information from this document. To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness, a clinical study report, or similar technical documentation submitted to the FDA for review.
§ 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.