THD Procto Software System

System, Imaging, Pulsed Echo, Ultrasonic

THD SpA

The following data is part of a premarket notification filed by Thd Spa with the FDA for Thd Procto Software System.

Pre-market Notification Details

Device IDK193512
510k NumberK193512
Device Name:THD Procto Software System
ClassificationSystem, Imaging, Pulsed Echo, Ultrasonic
Applicant THD SpA Via Dell'Industria, 1 Correggio,  IT 42015
ContactFilippo Bastia
CorrespondentFilippo Bastia
THD SpA Via Dell'Industria, 1 Correggio,  IT 42015
Product CodeIYO  
CFR Regulation Number892.1560 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyRadiology
510k Review PanelRadiology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-18
Decision Date2020-01-26

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