# K212012: Follicle Clarity

- Pathway: 510(k) (Traditional)
- Applicant: Cycle Clarity
- Decided: Jan 19, 2022 after 205 days
- Product code: QIH (Automated Radiological Image Processing Software)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 17 generations back to K935595 (1995). 87 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 89 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191647: QLAB Advanced Quantification Software, Philips Health Care (2019) Summary page 4.

## Most influential descendants
- K252332: Folliscan (2026), 0 descendants of its own

## Indications for use
Follicle Clarity Software is a software application package. It is designed to view and quantify image data acquired on compatible ultrasound systems. Follicle Clarity is used as an aid to interpreting clinicians by calculating the number and size of ovarian follicles in a transvaginal ultrasound volume sweep of the ovaries.

Source page: https://510kreport.com/device/K212012
Methodology: https://510kreport.com/methodology