# K252332: Folliscan

- Pathway: 510(k) (Traditional)
- Applicant: Mim Fertility
- Decided: Apr 20, 2026 after 269 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: 18 generations back to K935595 (1995). 88 ancestors in all.
No later device cites it as a predicate yet.
0 of 89 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212012: Follicle Clarity, Cycle Clarity (2022) Summary page 5.

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

Source page: https://510kreport.com/device/K252332
Methodology: https://510kreport.com/methodology