Oncentra Simulation 2.3

No FDA recalls found in the data synced 5 Oct 2026.

510(k) Number

K090706 ↗

FDA Product Code

KPQ

Device Class

Class II

Regulation

21 CFR Part 892.5840

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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See all devices from Nucletron Corp. →

• What is the Oncentra Simulation 2.3 software used for?

  The Oncentra Simulation 2.3 is a PC-based software system designed specifically for radiation therapy simulation. It processes images from devices like Simulix MC, HP, and HQ image intensifiers to enable functionalities such as image acquisition, enhancement, multi-view visualization, and database management. This aids clinical staff in radiation therapy departments by facilitating precise planning and alignment for radiation treatment procedures, ensuring accurate targeting during therapy.

• How is the Oncentra Simulation 2.3 supplied and does it require sterilization?

  The Oncentra Simulation 2.3 is supplied as a software application for PC platforms. Since it is a software-based system, it does not require sterilization or single-use considerations. It is intended for installation on compatible computers within radiation therapy departments, where it operates as part of the simulation workflow.

• Is the Oncentra Simulation 2.3 compatible with MRI environments?

  Yes, the Oncentra Simulation 2.3 is designed to operate within MRI-safe environments. This ensures that it can be safely used in settings where MRI equipment is present, reducing the risk of interference or safety hazards during radiation therapy planning and simulation.

• What regulatory pathway was followed for the Oncentra Simulation 2.3?

  The Oncentra Simulation 2.3 was cleared through the FDA’s Traditional 510(k) pathway under the product code KPQ, classified as a radiology system. It was determined to be substantially equivalent to the predicate device Simulix Evolution (K033470), adhering to Class 2 regulatory standards. This clearance allows its authorized use in radiology settings as outlined in the FDA’s clearance documentation.

• Does the Oncentra Simulation 2.3 support DICOM import and export?

  Yes, the Oncentra Simulation 2.3 includes support for DICOM (Digital Imaging and Communications in Medicine) import and export. This functionality allows seamless integration with other medical imaging systems and devices, enabling efficient data transfer and compatibility with existing workflows in radiation therapy departments.