THD Procto Software System— 510(k) K193512

Name: FDA 510(k) clearance K193512
Creator: U.S. Food and Drug Administration
Published: 2020-01-26

Substantially Equivalent

Thd Spa

FDA 510(k) clearance K193512 for THD Procto Software System, Substantially Equivalent on 2020-01-26. Applicant: Thd Spa. Device class: 2.

Clearance details

Applicant: Thd Spa
Product code: Code IYO
Device class: Class 2
Regulation: 21 CFR 892.1560
Advisory panel: Radiology
Date received: 2019-12-18
Decision date: 2020-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Correggio, IT

Download summary PDF View on FDA.gov ↗

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K211623 — THD Procto Software System2021-06-24
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K141657 — THD REVOLUTION2015-02-24
K133687 — THD N-ANO ANOSCOPE2013-12-11

Adverse events under product code IYO

product code IYO

Malfunction: 3,339
Total: 3,339

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.