Home GUDID 00864124000137
Vaginal Tactile Ultrasound Imager
Primary DI 00864124000137
Brand Vaginal Tactile Ultrasound Imager
Company Advanced Tactile Imaging, Inc.
Model 3S
Device description 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.
Published 2026-04-23
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name HIR Perineometer IYN System, Imaging, Pulsed Doppler, Ultrasonic IYO System, Imaging, Pulsed Echo, Ultrasonic
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HIR Perineometer Obstetrics/Gynecology 2 IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology 2 IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00864124000137 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00864124000137 00864124000137 864124000137 0864124000137
GMDN Terms# Term, Definition table Term Definition Pelvic floor tactile imaging system A mobile, mains electricity (AC-powered) assembly of devices intended to quantitatively measure, map, and display pelvic floor elasticity/strength values (e.g., pressure mapping of pelvic floor structures, pelvic floor muscle strength during muscle contractions) to aid the diagnosis and evaluation of vaginal and pelvic floor conditions. It consists of a central analysis unit with dedicated software, a monitor, and a transvaginal probe with built-in pressure/motion sensors.
Regulatory Flags# DUNS number 078793844 Device count 1 Serial number true Manufacturing date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00864124000106 Vaginal Tactile Imager 2S 2020-11-10
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