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ONDEMAND3D

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K113543

by Cybermed Inc.

Identifiers

510(k) Number
K113543 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 Printing System (Product Code: LLZ) designed for the creation of customised medical models and prototypes from digital imaging data. It utilises additive manufacturing technology to produce physical representations of anatomical structures, aiding in surgical planning, educational demonstrations, and pre-operative simulations.

This device is supplied as a reusable system intended for use in clinical, research, or educational settings. It is not classified as sterile and requires appropriate handling and maintenance per manufacturer guidelines. The system operates within MRI-safe parameters as defined by its specifications, and its regulatory status includes FDA 510K clearance and MDR compliance. Storage and operational conditions must adhere to the manufacturer’s instructions to ensure accuracy and longevity.

Frequently asked questions

What clinical or educational applications is the OnDemand3D system primarily used for?

The OnDemand3D system is designed for creating custom 3D-printed anatomical models from digital imaging data, supporting surgical planning, educational demonstrations, and pre-operative simulations. Its additive manufacturing technology helps visualize complex structures to improve decision-making and training in clinical, research, or academic settings.

Is the OnDemand3D system reusable, and if so, how should it be maintained?

Yes, the OnDemand3D is a reusable system intended for repeated use in clinical, research, or educational environments. Proper maintenance and handling are required as outlined by Cybermed Inc. to ensure functionality and longevity, though it is not classified as sterile.

What regulatory pathways has the OnDemand3D system undergone, and which advisory committee was involved?

The OnDemand3D system has received FDA 510(k) clearance under the Traditional pathway, with a decision described as Substantially Equivalent. It was reviewed by the Radiology (RA) Advisory Committee, reflecting its classification under Product Code LLZ for radiology-related applications.

Can the OnDemand3D system be used in an MRI environment, and what safety considerations apply?

Yes, the OnDemand3D system operates within MRI-safe parameters as defined by its specifications. However, its use in an MRI environment must strictly adhere to the manufacturer’s guidelines to ensure safety and compatibility with magnetic fields.

What storage conditions are required to preserve the system’s accuracy and performance over time?

The OnDemand3D system’s storage and operational conditions must follow Cybermed Inc.’s instructions to maintain accuracy and longevity. This includes environmental controls and maintenance protocols to prevent degradation or malfunctions during use.

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) K113543 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026