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THD Procto Software System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K211623

by Thd Spa

Identifiers

510(k) Number
K211623 FDA 510(k)
FDA Product Code
IYO FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1560 FDA 510(k)
Regulation Number
892.1560 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

THD Procto Software System by Thd Spa — Class II — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Thd Spa

Sources (1)

  • FDA 510(k) K211623 24 fields · synced Jun 18, 2026