Portable X-ray System (Model: MINIX-V / MINIX-S)— 510(k) K152859

Name: FDA 510(k) clearance K152859
Creator: U.S. Food and Drug Administration
Published: 2015-12-03

Substantially Equivalent

Digimed Co., Ltd. (Digimed Corporation Until 31/12/2012)

FDA 510(k) clearance K152859 for Portable X-ray System (Model: MINIX-V / MINIX-S), Substantially Equivalent on 2015-12-03. Applicant: Digimed Co., Ltd. (Digimed Corporation Until 31/12/2012). Device class: 2.

Clearance details

Applicant: Digimed Co., Ltd. (Digimed Corporation Until 31/12/2012)
Product code: Code EHD
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 2015-09-30
Decision date: 2015-12-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

Recent devices under product code EHD

view all

K260367 — Portable Dental X-ray System Model PDX nova2026-05-27
K253864 — NOMAD Pro 32026-03-20
K252110 — Dental X-RAY Unit (AJX200)2026-03-12
K254018 — Portable Dental X-ray Device (GT-1)2026-02-19
K252909 — Diagnostic X-Ray Equipment Model POCT222026-02-03

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