Halcyon Bracket

Basic Information

• Brand Name: Halcyon Bracket
• Primary DI: 05060608880195
• Version / Model: 1231405Z
• Catalog Number: 1231405Z
• Company Name: SUN NUCLEAR CORP.
• Labeler DUNS: 122240021
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-05-21
• Public Version: 1
• Public Version Date: 2019-05-29
• Public Version Status: New
• Public Device Record Key: 74845683-d3c2-4949-b32a-a6270df406ea

Device Description

The Halcyon Bracket is an accessory to the 3D SCANNER system and provides an electrical connection to the 3D SCANNER motors when the 3D SCANNER Water Tank is used with the Varian Halcyon delivery system.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IYE	Accelerator, Linear, Medical	Radiology	892.5050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38399	Accelerator system quality assurance device	An instrument specifically designed to be used to check the calibration and performance of linear and non-linear medical accelerator systems used for radiation therapy applications, for quality assurance (QA) purposes. It includes a variety of instruments used to measure parameters associated with particle and photon beam production, beam quality, and other system performance parameters.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060608880195	GS1

Premarket Submissions

Submission Number	Supplement Number
K101992	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Ensure that all 3D SCANNER parts and accessories are clean and dry before storing. For cleaning and storage instructions, see the 3D SCANNER Hardware Reference Guide.
• Type: Special Storage Condition, Specify
• Special Conditions: Store the 3D SCANNER system and accessories in an indoor, climate-controlled environment where they will not be irradiated by the direct beam and where scattered radiation will be kept at a minimum.
• Type: Handling Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: -30 – 50 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 10 – 40 Degrees Celsius