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
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 06927394503211 K-fit Hunan Accurate Bio-Medical Technology Co., Ltd. HIR 2026-09-05 08800010500840 SonoSync+ SAMSUNG MEDISON CO., LTD. IYN 2026-08-18 08800010500840 SonoSync+ SAMSUNG MEDISON CO., LTD. IYO 2026-08-18 08800357291937 V6 ONE Diagnostic Ultrasound System SAMSUNG MEDISON CO., LTD. IYN 2026-08-18 08800357291937 V6 ONE Diagnostic Ultrasound System SAMSUNG MEDISON CO., LTD. IYO 2026-08-18 08800357300165 V7 ONE Diagnostic Ultrasound System SAMSUNG MEDISON CO., LTD. IYN 2026-08-18 08800357300165 V7 ONE Diagnostic Ultrasound System SAMSUNG MEDISON CO., LTD. IYO 2026-08-18 08800357308208 V8 ONE Diagnostic Ultrasound System SAMSUNG MEDISON CO., LTD. IYN 2026-08-18 08800357308208 V8 ONE Diagnostic Ultrasound System SAMSUNG MEDISON CO., LTD. IYO 2026-08-18 00841436125420 Tracking Bracket CIVCO MEDICAL INSTRUMENTS CO., INC. IYO 2026-07-27 00841436126212 Tracking Bracket Starter Kit CIVCO MEDICAL INSTRUMENTS CO., INC. IYO 2026-07-27 00841436126229 Tracking Bracket CIVCO MEDICAL INSTRUMENTS CO., INC. IYO 2026-07-27 00841436126328 Tracking Bracket CIVCO MEDICAL INSTRUMENTS CO., INC. IYO 2026-07-27 00841436126588 Tracking Bracket Starter Kit CIVCO MEDICAL INSTRUMENTS CO., INC. IYO 2026-07-27 00841436126595 Tracking Bracket CIVCO MEDICAL INSTRUMENTS CO., INC. IYO 2026-07-27 00841436125413 Tracking Bracket Starter Kit CIVCO MEDICAL INSTRUMENTS CO., INC. IYO 2026-07-23 00841436126311 Tracking Bracket Starter Kit CIVCO MEDICAL INSTRUMENTS CO., INC. IYO 2025-12-31 00195278439352 LOGIQ GE Medical Systems, Ultrasound & Primary Care Diagnostics LLC IYN 2025-12-05 00195278439352 LOGIQ GE Medical Systems, Ultrasound & Primary Care Diagnostics LLC IYO 2025-12-05 00195278439369 LOGIQ GE Medical Systems, Ultrasound & Primary Care Diagnostics LLC IYN 2025-12-05 00195278439369 LOGIQ GE Medical Systems, Ultrasound & Primary Care Diagnostics LLC IYO 2025-12-05 00195278723963 NA GE Healthcare Japan Corporation IYO 2025-10-15 00195278723963 NA GE Healthcare Japan Corporation IYN 2025-10-15 00884838129276 Ultrasound Workspace Philips Ultrasound LLC IYN 2025-08-29 00195278875860 Vscan GE Vingmed Ultrasound A/S IYN 2025-07-04 00195278875860 Vscan GE Vingmed Ultrasound A/S IYO 2025-07-04 00195278910509 Voluson GE Ultrasound Korea Ltd. IYO 2025-06-04 00195278910509 Voluson GE Ultrasound Korea Ltd. IYN 2025-06-04 00884838125186 Ultrasound Workspace Philips Ultrasound LLC IYN 2025-03-24 00195278814685 Voluson GE Healthcare Austria GmbH & Co OG IYN 2025-01-08