FDA.reportPublic FDA data

ADVANCED TACTILE IMAGING, INC.

Matched from indexed company URL: Advanced Tactile Imaging, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30112788983011278898ADVANCED TACTILE IMAGING, INC.1N2026-01-011457 Lower Ferry Rd Trenton NJ US 08618

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1763271494445798K231875Vaginal Tactile Ultrasound ImagerHIR2024-02-22
1763271832796213K142355Vaginal Tactile ImagerHIR2015-05-28

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HIR22024-02-22

PMN#

GUDID#

Vaginal Tactile Ultrasound Imager - 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.

Advanced Tactile Imaging, Inc.

2026-04-23