# K111361: Planmed Nuance Excel

- Pathway: 510(k) (Traditional)
- Applicant: Planmeca USA, Inc.
- Decided: Sep 23, 2011 after 130 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 P030010 (2004). 1 ancestor in all.
4 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P030010: Siemens Mammomat Novationdr Full Field Digital Mammography System, Siemens Medical Solution (2004) Summary page 2.

## Most influential descendants
- K163328: Planmed Clarity (2017), 3 descendants of its own
- K192317: Planmed Clarity 2D and Clarity S (2020), 1 descendant of its own
- K211720: Planmed Clarity 2D, Planmed Clarify S (2022), 0 descendants of its own
- K202822: Helianthus (2021), 0 descendants of its own

## Indications for use
Planmed Nuance Excel is a FFDM (Full Field Digital Mammography) X-ray unit, which is intended to be used for screening and diagnosis of breast cancer in the same clinical applications as traditional film/screen mammography X-ray units. The system generates digital mammograms which enable to detect breast cancer at an early stage. The use of Planmed FFDM X-ray unit is allowed only under supervision of a health care professional.

Source page: https://510kreport.com/device/K111361
Methodology: https://510kreport.com/methodology