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Dicompacs Model 5

by Oehm Und Rehbein GmbH

510(k) K070618

Active European Union and United States

CE MDR 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) K070618↗

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 NumberK070618 Date25 Apr 2007ClearedStatusActive
European UnionCE/MDR 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  • Withdrawn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/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
LLZ
Device Class
Class II
Regulation
21 CFR Part 892.2050
Advisory Committee
Radiology
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.

The Dicompacs Model 5 is a Class II X-ray system designed for radiology applications. It functions as a diagnostic imaging device, enabling the capture and display of radiographic images for medical evaluation.

This device is supplied by OEHM UND REHBEIN GMBH and is regulated under FDA 510(k) clearance (K070618) and the Medical Device Regulation (MDR). It is intended for use in radiology settings and is classified under product code LLZ, with a traditional review pathway. No specific sterility, single-use, or MRI safety details are provided in the available data.

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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 type of medical facility or department is the Dicompacs Model 5 intended for use in?

    The Dicompacs Model 5 is specifically designed for radiology departments within medical facilities. As a Class II X-ray system, it is intended for capturing and displaying radiographic images to aid in medical evaluation, making it a core tool for diagnostic imaging workflows.

  • How is the Dicompacs Model 5 regulated, and what does that mean for its use in clinical settings?

    The Dicompacs Model 5 is regulated under both the FDA’s 510(k) clearance process (with clearance number K070618) and the European Medical Device Regulation (MDR). This means it has undergone evaluation to ensure it meets safety and performance standards for diagnostic X-ray imaging, allowing it to be legally used in radiology settings in the U.S. and EU. The traditional review pathway (product code LLZ) indicates a standard FDA assessment process.

  • Is the Dicompacs Model 5 a single-use device, or is it meant for repeated use in a clinical environment?

    The available data does not specify whether the Dicompacs Model 5 is single-use or reusable. Since it is an X-ray imaging system, it is likely designed for repeated use in clinical settings, but users should refer to the manufacturer’s instructions for maintenance, cleaning, and reprocessing guidelines to ensure proper functionality and compliance with regulatory requirements.

  • What does the advisory committee description “Radiology” indicate about the Dicompacs Model 5?

    The advisory committee description ‘Radiology’ for the Dicompacs Model 5 indicates that its development and regulatory review were overseen by the FDA’s Radiological Devices Advisory Committee (RA). This committee provides expert input on X-ray and imaging devices, confirming that the device’s design, safety, and performance were evaluated with a focus on radiology-specific applications and standards.