# K013656: Planmed Sophie & Planmed Sophie Classic

- Pathway: 510(k) (Traditional)
- Applicant: Planmed OY
- Decided: Jan 16, 2002 after 71 days
- Product code: IZH (System, X-Ray, Mammographic)
- Device class: 2
- Regulation: 21 CFR 892.1710
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K042671: Planmed Sophie Nuance Classic (2004), 0 descendants of its own

## Indications for 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.

Source page: https://510kreport.com/device/K013656
Methodology: https://510kreport.com/methodology