SunSCAN 3D 1235900Z

GUDID 05060608881130

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.

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• Primary Device ID: 05060608881130
• NIH Device Record Key: 3fc718af-46bf-4f57-bb0d-8e78b2f8672a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SunSCAN 3D
• Version Model Number: 1235
• Catalog Number: 1235900Z
• 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	05060608881130 [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