# K222683: Fibroid Mapping Reviewer Application (FMRA)

- Pathway: 510(k) (Traditional)
- Applicant: Nesa Medtech Private Limited
- Decided: Jul 17, 2023 after 314 days
- Product code: LLZ (System, Image Processing, Radiological)
- 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: 5 generations back to K954678 (1996). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081093: 3-D Imaging Workstation, Eigen, LLC (2008) Summary page 4.

## Indications for use
Fibroid Mapping Reviewer Application (FMRA) is intended to be used by physicians in the clinic or hospital to generate a 3-D model from ultrasound images of the uterus of women with uterine fibroids. The model represents clinically relevant dimensions, including the location and dimensions of the fibroid (maximum length, width and depth).

Source page: https://510kreport.com/device/K222683
Methodology: https://510kreport.com/methodology