# K231875: Vaginal Tactile Ultrasound Imager

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Tactile Imaging, Inc.
- Decided: Feb 22, 2024 after 241 days
- Product code: HIR (Perineometer)
- Device class: 2
- Regulation: 21 CFR 884.1425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K011472 (2001). 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)
- K142355: Vaginal Tactile Imager, Advanced Tactile Imaging, Inc. (2015) Summary page 6.

## Indications for use
The Vaginal Tactile Ultrasound Imager obtains high-resolution mapping of pressures, ultrasound images and assesses the strength of pelvic floor muscles within the vagina. It is used in a medical setting to acquire the pressures, ultrasound images and store the corresponding data. It also provides visualization, analysis tools and information. The real time data as well as the analysis information can then be viewed with an intention of assisting in the diagnosis and evaluation. The device is intended for use by physicians, surgeons and medically trained personnel.

Source page: https://510kreport.com/device/K231875
Methodology: https://510kreport.com/methodology