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K Number
K021945
Device Name
PLANMED SOPHIE & SOPHIE CLASSIC (WITH DIGISPOT AND CYTOGUIDE)
Manufacturer
PLANMED OY
Date Cleared
2003-02-21

(253 days)

Product Code
IZH
Regulation Number
892.1710
Type
Traditional
Panel
RA
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

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, as spot mammography and stereotactic breast needle biopsy.

Device Description

Planmed Sophie and Sophie Classic (with Digispot and Cytoguide)

AI/ML Overview

This document is a 510(k) premarket notification acceptance letter for the PlanMed Sophie and Sophie Classic Mammographic X-ray Systems. It does not contain the information requested about acceptance criteria and a study proving a device meets these criteria. This type of information would typically be found in a detailed submission document or a clinical study report, not in the FDA's acceptance letter which only states that the device is substantially equivalent to a legally marketed predicate device.

§ 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.