SunSCAN 3D 1234900Z

GUDID 05060608881123

The SunSCAN 3D, model 1234/1235, is intended for radiotherapy dosimetry measurements and export of those measurements for commissioning a Treatment Planning System (TPS) computer. It is also intended for periodic beam Quality Assurance (QA) tests as defined by the medical physicist responsible for the QA program.

SUN NUCLEAR CORP.

Accelerator system quality assurance device

• Primary Device ID: 05060608881123
• NIH Device Record Key: 8f6cb06b-b124-4fa0-b65e-70b3d9c1299a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SunSCAN 3D
• Version Model Number: 1234
• Catalog Number: 1234900Z
• Company DUNS: 122240021
• Company Name: SUN NUCLEAR CORP.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060608881123 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101992

FDA Product Code

• IYE: Accelerator, Linear, Medical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-16
• Device Publish Date: 2023-06-08

On-Brand Devices [SunSCAN 3D]

• 05060608881130: The SunSCAN 3D, model 1234/1235, is intended for radiotherapy dosimetry measurements and export
• 05060608881123: The SunSCAN 3D, model 1234/1235, is intended for radiotherapy dosimetry measurements and export