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Vaginal Tactile Ultrasound Imager 3S

by Advanced Tactile Imaging Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00864124000137 UDI-DI Date23 Apr 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Vaginal Tactile Ultrasound Imager
Generic Name
Pelvic floor tactile imaging system
Model / Reference
3S
Primary DI / UDI-DI
00864124000137
510(k) Number
FDA Product Code
HIR, IYO, IYN
GMDN Term
Pelvic floor tactile imaging system
Device Class
Class II
Regulation Number
884.1425, 892.1560, 892.1550
GUDID distribution status
In Commercial Distribution

Other devices from Advanced Tactile Imaging Inc.

Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No