Cleared Traditional

THD Procto Software System

K193512 · Thd Spa · Radiology
Jan 2020
Decision
39d
Days
Class 2
Risk

About This 510(k) Submission

K193512 is an FDA 510(k) clearance for the THD Procto Software System, a System, Imaging, Pulsed Echo, Ultrasonic (Class II — Special Controls, product code IYO), submitted by Thd Spa (Correggio, IT). The FDA issued a Cleared decision on January 26, 2020, 39 days after receiving the submission on December 18, 2019. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1560.

Submission Details

510(k) Number K193512 FDA.gov
FDA Decision Cleared SESE
Date Received December 18, 2019
Decision Date January 26, 2020
Days to Decision 39 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IYO — System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1560

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