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 DIGITAL MOBILE MANOMETRY is an integrated mobile proctological platform for the Colo-Rectal Surgeon/ Proctologist which allows the proctologist to have a single, modular and expandable diagnostic system to perform anorectal manometry. THD DIGITAL MOBILE MANOMETRY has a Laptop with Windows® operating system, pre-installed medical software for electronic capture, storage and reporting (THD Procto Software REF. 760004), a HD VideoCamera connected via USB cable to Digital Mobile for outpatient diagnostics using our line of N-Ano diagnostic anoscopes and THD Anopress (transportable anorectal manometer) for anorectal manometry. FDA UDI
Model / Reference: THD DIGITAL MOBILE MANOMETRY FDA UDI
Description: THD DIGITAL MOBILE MANOMETRY is an integrated mobile proctological platform for the Colo-Rectal Surgeon/ Proctologist which allows the proctologist to have a single, modular and expandable diagnostic system to perform anorectal manometry. THD DIGITAL MOBILE MANOMETRY has a Laptop with Windows® operating system, pre-installed medical software for electronic capture, storage and reporting (THD Procto Software REF. 760004), a HD VideoCamera connected via USB cable to Digital Mobile for outpatient diagnostics using our line of N-Ano diagnostic anoscopes and THD Anopress (transportable anorectal manometer) for anorectal manometry. FDA UDI

Identifiers

Catalog Number: 800307 FDA UDI
Primary DI / UDI-DI: 68051887043301 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
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

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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 cde7d928-9396-42c1-b7e1-c78f40059f9f 36 fields · synced Jun 8, 2026