Identity
- Trade Name
- CT Sim+ FDA UDI
- Generic Name
- Laser patient positioning system FDA UDI
- Device Name
- The CT Sim+, 1-Arm, Red 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. FDA UDI
- Model / Reference
- CT Sim+ FDA UDI
- Description
- The CT Sim+, 1-Arm, Red 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. FDA UDI
Identifiers
- Catalog Number
- 805757 FDA UDI
- Primary DI / UDI-DI
- B1361000RRC0 FDA UDI
- FDA Product Code
- IWE FDA UDI
- GMDN Term
- Laser patient positioning system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 892.5780 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Laser patient positioning system
CT Sim+ by Sun Nuclear Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Sun Nuclear Corporation
Sources (1)
- FDA UDI 781f5ae4-7845-4304-ba32-384f5825ae9e 35 fields · synced Jun 8, 2026