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 HRStation is an integrated proctological station mainly dedicated to the diagnosis of pathologies of the anal canal and specifically to the diagnosis of precancerous lesions. Thanks to the THD Procto Software, it allows the proctologist to have a unique, modular and expandable diagnostic system that, in addition to the realization of high resolution anoscopy, can also allow further diagnostic investigations such as anorectal manometry and Transanal ultrasound. FDA UDI
Model / Reference: THD HRStation FDA UDI
Description: THD HRStation is an integrated proctological station mainly dedicated to the diagnosis of pathologies of the anal canal and specifically to the diagnosis of precancerous lesions. Thanks to the THD Procto Software, it allows the proctologist to have a unique, modular and expandable diagnostic system that, in addition to the realization of high resolution anoscopy, can also allow further diagnostic investigations such as anorectal manometry and Transanal ultrasound. FDA UDI

Identifiers

Catalog Number: 800299 FDA UDI
Primary DI / UDI-DI: 58051887042642 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

Yes

FDA UDI

Serial Number

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.

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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

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Manufacturer

Manufacturer: Thd Spa

Sources (1)

FDA UDI 363ab120-d4d8-460f-8102-3ef0ac40a440 36 fields · synced May 30, 2026