gudid
Primary ID: 805428
CT Sim (UDI 805428)
Manufactured by SUN NUCLEAR CORP.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for CT Sim - Primary ID 805428
Device Regulatory Overview
The CT Sim (Model/Catalog Number: 805428) 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
- 805428
- Product Code / EMDN
- IWE
- Device Name
- Gammex CT Sim Laser systems are 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 specified file 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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Get API Token Access ($49/mo)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 805428.
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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