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Portable X-ray System (Model: MINIX-V / MINIX-S)

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

510(k) K152859

Active European Union and United States

CE MDD 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K152859↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK152859 Date3 Dec 2015ClearedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
EHD
Device Class
Class II
Regulation
21 CFR Part 872.1800
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a portable extraoral X-ray system with a timer, classified as a Class II medical device. It is designed for dental radiography, providing high-resolution imaging for diagnostic purposes in intraoral and extraoral dental applications. The system delivers precise X-ray output for capturing detailed images of teeth, jawbone, and surrounding structures, aiding in the assessment of dental conditions and treatment planning.

The Portable X-ray System (Models: MINIX-V, MINIX-S) is intended for use in dental clinics, offices, and mobile dental units. It is supplied as a reusable device, requiring proper maintenance and calibration to ensure accurate and safe operation. The system is not MRI-compatible and must be stored in a controlled environment to protect against physical damage and contamination. Authorized for use under FDA 510(k) clearance and MDD compliance, it adheres to regulatory standards for dental X-ray imaging.

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of dental imaging can this portable X-ray system perform, and where is it typically used?

    The Portable X-ray System (Models MINIX-V and MINIX-S) is designed for both intraoral and extraoral dental radiography, delivering high-resolution images of teeth, jawbone, and surrounding structures. It is specifically intended for use in dental clinics, offices, and mobile dental units to aid in diagnosing dental conditions and planning treatments.

  • Is this device single-use or reusable, and what maintenance is required?

    This system is a reusable device, meaning it is designed for repeated use in clinical settings. To ensure accurate and safe operation, it requires proper maintenance and regular calibration as part of its upkeep. The manufacturer emphasizes adherence to these procedures to maintain performance standards.

  • How should this portable X-ray system be stored to ensure its longevity and safety?

    The Portable X-ray System must be stored in a controlled environment to protect it from physical damage and contamination. Since it is not MRI-compatible, it should also be kept away from magnetic fields or environments where such interference could occur.

  • What regulatory approvals does this device hold, and how does that affect its use?

    The Portable X-ray System holds FDA 510(k) clearance and complies with the Medical Device Directive (MDD). These approvals confirm that the device meets regulatory standards for dental X-ray imaging in the United States and European Economic Area, respectively, ensuring its safety and effectiveness for the intended dental applications.