# K042671: Planmed Sophie Nuance Classic

- Pathway: 510(k) (Traditional)
- Applicant: Planmed OY
- Decided: Nov 19, 2004 after 51 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
Longest line of descent: 1 generation back to K904953 (1991). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K904953: Planmed Sophie, Planmeca USA, Inc. (1991) Summary page 1.
- K923471: Planmed Cytoguide, Planmed OY (1992) Summary page 2.
- K951883: Planmed Sophie Mammographic X-Ray Unit, Planmed OY (1995) Summary page 2.
- K962105: Planned Sophied Classic, Planmed OY (1997) Summary page 2.
- K973493: Planmed Cytoguide, Planmed OY (1997) Summary page 2.
- K983659: Planmed Sophie & Planned Sophie Classic, Planmed OY (1998) Summary page 2.
- K991826: Planmed Sophie and Sophie Classic, Planmed OY (1999) Summary page 2.
- K013656: Planmed Sophie & Planmed Sophie Classic, Planmed OY (2002) Summary page 2.

## Indications for use
The Planmed Sophie Nuance Classic is a mammography x-ray system, which is intended to be used to produce radiographs of the human breast. The device can be equipped with accessories to fulfil different diagnostic needs. Spot mammography is only used in combination with stereotactic needle biopsy guidance.

Source page: https://510kreport.com/device/K042671
Methodology: https://510kreport.com/methodology