gudid Primary ID: CT Sim+

CT Sim+ (UDI CT Sim+)

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The CT Sim+ (Model/Catalog Number: CT Sim+) is a medical device manufactured by SUN NUCLEAR CORP.. This product is indexed under FDA Product Code / Category Classification IWE within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: CT Sim+
Product Code / EMDN: IWE
Device Name: The CT Sim+, 1-Arm, Blue Laser is used in the simulation stage of radiation therapy to prepare a patient for treatment. The lasers can be moved to a point that defines the radiation treatment isocenter or can be used to define the center of the CT imager. The Gammex CT Sim+ is intended to read laser positioning coordinates in a DICOM or Gammex specified software format. Typically the coordinates are calculated by a Radiation Therapy Treatment Planning System (RTPS) or CT Virtual Simulation System.
Database Sync Date: 2026-08-09 09:43:55

Full Regulatory Attributes

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{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}

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Frequently Asked Questions

Who is the primary manufacturer of CT Sim+?

The registered manufacturer of record for CT Sim+ is SUN NUCLEAR CORP..

What is the Primary UDI-DI identifier for CT Sim+?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is CT Sim+.

What classification code is assigned to this device?

This device is registered under product classification code IWE.

Similar Classification Devices (IWE)

Other Devices by SUN NUCLEAR CORP.

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