Heuron ICH— 510(k) K233247

Substantially Equivalent

Heuron Co., Ltd.

FDA 510(k) clearance K233247 for Heuron ICH, Substantially Equivalent on 2024-05-15. Applicant: Heuron Co., Ltd.. Device class: 2.

Clearance details

Applicant: Heuron Co., Ltd.
Product code: Code QAS
Device class: Class 2
Regulation: 21 CFR 892.2080
Advisory panel: Radiology
Date received: 2023-09-28
Decision date: 2024-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

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