3D TPR 1230000-4Z

GUDID 05060608880928

Accessory to the 1230 3D SCANNER used to measure the Tissue Phantom Ratio.

SUN NUCLEAR CORP.

Accelerator system quality assurance device

• Primary Device ID: 05060608880928
• NIH Device Record Key: d2eadf9b-563a-4274-9e37-21b104d2da71
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3D TPR
• Version Model Number: 1230000-4Z
• Catalog Number: 1230000-4Z
• 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: true
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Ensure that all 3D TPR parts, including cable and connector, are clean and dry before placing in storage case. Dry with soft cloth. Never use abrasive cleaners.

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060608880928 [Primary]
HIBCC	B01612300004Z0 [Previous]

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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-06-30
• Device Publish Date: 2019-08-02

Devices Manufactured by SUN NUCLEAR CORP.

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• 05060608881208 - SunSILICON P: 2025-07-16 The SunSILICON P detector is intended for use as a relative dosimetry detector in measurements of ionizing radiation emitted fro
• 05060608881512 - Precision Cut GafChromic™ Film: 2024-11-11 Radiographic film
• 05060608881178 - Precision Cut EBT3 GafChromic™ Film: 2024-01-10 Precision Cut EBT3 GafChromic™ Film
• 05060608881123 - SunSCAN 3D: 2023-06-16 The SunSCAN 3D, model 1234/1235, is intended for radiotherapy dosimetry measurements and export of those measurements for commis
• 05060608881130 - SunSCAN 3D: 2023-06-16 The SunSCAN 3D, model 1234/1235, is intended for radiotherapy dosimetry measurements and export of those measurements for commis
• 05060608880041 - rf-IVD 2: 2020-08-03 Radiation therapy QA device.
• 05060608880874 - PlanIQ: 2020-08-03 Radiation therapy QA software.