# K121963: Planmed Nuance Digiguide

- Pathway: 510(k) (Traditional)
- Applicant: Planmed OY
- Decided: Nov 21, 2012 after 139 days
- Product code: MUE (Full Field Digital, System, X-Ray, Mammographic)
- Device class: 2
- Regulation: 21 CFR 892.1715
- 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 K021945 (2003). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021945: Planmed Sophie & Sophie Classic (with Digispot and Cytoguide), Planmed OY (2003) Summary page 2.

## Indications for use
Planined Nuance DigiGuide is an optional system for Stereotactic Biopsy. It consists of a needle guidance unit attached to Planmed Nuance or Plantmed Nuance Excel digital mammography X-ray units and DigiGuide software module for Nuance Manager 3 acquisition software. The system is used for needle sampling of women's breast tissues for examination. The use of Plantmed Nuance DigiGuide is allowed only under supervision of a health care professional.

Source page: https://510kreport.com/device/K121963
Methodology: https://510kreport.com/methodology