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ONDEMAND3D

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K070464

by Cybermed Inc.

Identifiers

510(k) Number
K070464 FDA 510(k)
FDA Product Code
LLZ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.2050 FDA 510(k)
Regulation Number
892.2050 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The OnDemand3D is a 3D Medical Imaging Workstation (Product Code: LLZ) designed for the reconstruction and visualization of volumetric medical imaging data. It processes and renders three-dimensional images from sources such as CT, MRI, or ultrasound scans, enabling clinicians to analyze anatomical structures with enhanced clarity and precision.

This device is supplied as a reusable, non-sterile system intended for use in radiology departments or imaging centers. It requires proper installation and maintenance in compliance with FDA and MDR regulations, with no specific MRI safety classification noted. The system operates under a Traditional 510(k) clearance (K070464) and is intended for institutional use only, adhering to manufacturer guidelines for storage and operational conditions.

Frequently asked questions

What types of medical imaging data can the OnDemand3D workstation process and visualize, and why is this important for clinicians?

The OnDemand3D is designed to process and render volumetric medical imaging data from sources like CT, MRI, and ultrasound scans. This capability is important for clinicians because it allows them to reconstruct and analyze anatomical structures in three dimensions, improving diagnostic accuracy and precision during evaluations.

Is the OnDemand3D system reusable or single-use, and what does this mean for maintenance and operational workflows?

The OnDemand3D is a reusable, non-sterile system, meaning it is built for long-term use in radiology departments or imaging centers. This design implies that it requires regular installation, maintenance, and cleaning per manufacturer guidelines to ensure consistent performance and compliance with regulatory standards like FDA and MDR.

What kind of environment is the OnDemand3D intended for, and are there any special considerations for its installation or use?

The OnDemand3D is intended for institutional use in radiology departments or imaging centers. Since it is not classified for MRI safety, it must be installed and operated in compliance with FDA and MDR regulations, ensuring proper environmental conditions and adherence to manufacturer guidelines for optimal functionality and safety.

How does the OnDemand3D’s regulatory clearance impact its use in clinical settings, particularly regarding compliance and third-party involvement?

The OnDemand3D holds a Traditional 510(k) clearance (K070464) under the FDA and MDR, indicating it is deemed substantially equivalent to a legally marketed predicate device. This clearance confirms its compliance with regulatory standards, and the third-party flag marked as 'Y' suggests third-party review was involved in the approval process, which may influence procurement and validation workflows in clinical settings.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Cybermed Inc.
FDA Applicant
Cybermed, Inc.

Sources (2)

  • FDA 510(k) K070464 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced Jun 4, 2026