# K163328: Planmed Clarity

- Pathway: 510(k) (Traditional)
- Applicant: Planmed OY
- Decided: Dec 28, 2017 after 395 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: 2 generations back to P030010 (2004). 2 ancestors in all.
3 later devices descend from it; 2 cite 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)
- K111361: Planmed Nuance Excel, Planmeca USA, Inc. (2011) Summary page 4.

## Most influential descendants
- 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
The Planmed Clarity 2D mammography unit acquires digital 2D mammographic images. The Planmed Clarity 2D system is intended to be used for screening and diagnosis of breast cancer. The Planmed Clarity system may also be used for additional diagnostic workup of the breast.

Source page: https://510kreport.com/device/K163328
Methodology: https://510kreport.com/methodology