THD Procto Software System

FDA UDI

Class II (US FDA UDI)

by Thd Spa

Identity

Trade Name: THD Procto Software System FDA UDI
Generic Name: Ultrasound imaging system application software FDA UDI
Device Name: THD Proctostation is an integrated, modular and expandable one-stop platform for the Colo-Rectal Surgeon/Proctologist, to perform Anorectal manometry, EAUS and High Resolution Anoscopy. It includes: - THD Procto Software - proctology integrated software - Dedicated hardware composed of an All in One professional Personal Compuiter - Insulation Transformer - Procto Trolley with pivoting wheels, brakes and orientable dringging handle FDA UDI
Model / Reference: THD Proctostation FDA UDI
Description: THD Proctostation is an integrated, modular and expandable one-stop platform for the Colo-Rectal Surgeon/Proctologist, to perform Anorectal manometry, EAUS and High Resolution Anoscopy. It includes: - THD Procto Software - proctology integrated software - Dedicated hardware composed of an All in One professional Personal Compuiter - Insulation Transformer - Procto Trolley with pivoting wheels, brakes and orientable dringging handle FDA UDI

Identifiers

Catalog Number: 800198 FDA UDI
Primary DI / UDI-DI: 18033737712389 FDA UDI
510(k) Number: K211623 FDA UDI
FDA Product Code: IYO FDA UDI
KLA FDA UDI
ITX FDA UDI
FWG FDA UDI
OUG FDA UDI
NSX FDA UDI
GMDN Term: Ultrasound imaging system application software FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1560 FDA UDI
876.1725 FDA UDI
892.1570 FDA UDI
878.4160 FDA UDI
880.6310 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Ultrasound imaging system application software

THD Procto Software System by Thd Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ultrasound imaging system application software.

FETOLY-HEART — DIAGNOLY · Class II
Koios Medical — Koios Medical, Inc. · Class II
AmCAD UT Detection — AMCAD BIOMED CORPORATION · Class II
EchoPAC — Ge Vingmed Ultrasound · Class II
Clear Guide SCENERGY — Clear Guide Medical · Class II
See-Mode Technologies — See-Mode Technologies Pte, Ltd. · Class II
QVCAD System — Qview Medical, Inc. · Class II
EchoPAC — Ge Vingmed Ultrasound · Class II

Cleared under the same submission

K211623 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Thd Spa

Sources (1)

FDA UDI 35f8b0b2-d315-4e17-b5e2-97b5a135812b 36 fields · synced Jun 8, 2026