Cleared Special

THD Procto Software System

K211623 · Thd Spa · Radiology
Jun 2021
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K211623 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 June 24, 2021, 29 days after receiving the submission on May 26, 2021. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1560.

Submission Details

510(k) Number K211623 FDA.gov
FDA Decision Cleared SESE
Date Received May 26, 2021
Decision Date June 24, 2021
Days to Decision 29 days
Submission Type Special
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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