ExamVue Apex— 510(k) K244010

Substantially Equivalent

Jpi Healthcare Co, Ltd.

FDA 510(k) clearance K244010 for ExamVue Apex, Substantially Equivalent on 2025-02-24. Applicant: Jpi Healthcare Co, Ltd.. Device class: 2.

Clearance details

Applicant: Jpi Healthcare Co, Ltd.
Product code: Code MQB
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2024-12-26
Decision date: 2025-02-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

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More clearances from Jpi Healthcare Co, Ltd.

K260482 — DRE Duo2026-06-15
K213057 — ExamVue Duo2022-02-18
K142930 — Exam Vue DR2015-04-17
K102327 — CLEARVISION DR 7000F2012-04-13
K101779 — CLEARVISION DR 2000 DIGITAL RADIOGRAPHY X-RAY SYSTEM2011-05-16

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