Portable X-ray System (Model: MiniX-V, Mini X-S)— 510(k) K181891

Name: FDA 510(k) clearance K181891
Creator: U.S. Food and Drug Administration
Published: 2018-08-10

Substantially Equivalent

Digimed Co., Ltd.

FDA 510(k) clearance K181891 for Portable X-ray System (Model: MiniX-V, Mini X-S), Substantially Equivalent on 2018-08-10. Applicant: Digimed Co., Ltd.. Device class: 2.

Clearance details

Applicant: Digimed Co., Ltd.
Product code: Code EHD
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 2018-07-13
Decision date: 2018-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

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