# K211720: Planmed Clarity 2D, Planmed Clarify S

- Pathway: 510(k) (Traditional)
- Applicant: Planmed OY
- Decided: Jul 18, 2022 after 409 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: 4 generations back to P030010 (2004). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192317: Planmed Clarity 2D and Clarity S, Planmed OY (2020) Summary page 4.

## Indications for use
The Planmed Clarity 2D and S mammography units acquire digital 2D mammographic images. Both systems are intended to be used for screening and diagnosis of breast cancer. The Clarity 2D and S systems may also be used for additional diagnostic workup of the breast. Additionally, the Planmed Clarity 2D and S systems can be used to provide digital x-ray images of breast biopsy specimens.

Source page: https://510kreport.com/device/K211720
Methodology: https://510kreport.com/methodology