# K021945: Planmed Sophie & Sophie Classic (with Digispot and Cytoguide)

- Pathway: 510(k) (Traditional)
- Applicant: Planmed OY
- Decided: Feb 21, 2003 after 253 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
- K121963: Planmed Nuance Digiguide (2012), 0 descendants of its own

## Indications for use
The Planmed Sophie and Planmed Sophie Classic are Mammographic X-ray Systems, whch are intended to be used to produce radiographs of the human breast. The devices can be equipped with accessories to hlfil different diagnostic needs, as spot mammography and stereotactic breast needle biopsy.

Source page: https://510kreport.com/device/K021945
Methodology: https://510kreport.com/methodology