Data / Medical devices / United States / Advanced Tactile Imaging, Inc.
Advanced Tactile Imaging, Inc.: FDA-registered device maker in Trenton, NJ, United States, 2 510(k) clearances
Advanced Tactile Imaging, Inc. is registered with the FDA (registration 3011278898) in Trenton, NJ, United States. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated February 22, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011278898
- Address
- 1457 Lower Ferry Rd, Trenton, NJ, United States, 08618
- Owner or operator
- Advanced Tactile Imaging, Inc. (10047858)
- Roles
- Manufacturer
- First device listed
- August 18, 2016
- Registered through
- 2026
- Brand names listed
- Vaginal Tactile Imager, Vaginal Tactile Ultrasound Imager
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Perineometer | HIR | 2 | Manufacturer | accessdata.fda.gov |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | 2 | Manufacturer | accessdata.fda.gov |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 22, 2024 | K231875 | Vaginal Tactile Ultrasound Imager | HIR | Substantially Equivalent | Advanced Tactile Imaging, Inc. | accessdata.fda.gov |
| May 28, 2015 | K142355 | Vaginal Tactile Imager | HIR | Substantially Equivalent | Advanced Tactile Imaging, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Perineometer
- All makers of System, Imaging, Pulsed Doppler, Ultrasonic
- All makers of System, Imaging, Pulsed Echo, Ultrasonic
Updated February 22, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.