Medihub Prostate— 510(k) K233196

Substantially Equivalent

JLK, Inc.

FDA 510(k) clearance K233196 for Medihub Prostate, Substantially Equivalent on 2024-06-21. Applicant: JLK, Inc.. Device class: 2.

Clearance details

Applicant: JLK, Inc.
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2023-09-28
Decision date: 2024-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

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