SunSILICON

GUDID 05060608881192

The SunSILICON detector is intended for use as a relative dosimetry detector in measurements of ionizing radiation emitted from a treatment delivery device.

SUN NUCLEAR CORP.

Solid-state-semiconductor radiation measuring probe

• Primary Device ID: 05060608881192
• NIH Device Record Key: 75e77c91-96d8-4d5f-94be-c35fe8895c0e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SunSILICON
• Version Model Number: 1048
• Company DUNS: 122240021
• Company Name: SUN NUCLEAR CORP.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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

Customer Support Contacts

• Phone: +1 3212596862
• Email: globalsupport@sunnuclear.com
• Phone: +1 3212596862
• Email: globalsupport@sunnuclear.com
• Phone: +1 3212596862
• Email: globalsupport@sunnuclear.com
• Phone: +1 3212596862
• Email: globalsupport@sunnuclear.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060608881192 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051921

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: 2025-07-16
• Device Publish Date: 2025-07-08

Devices Manufactured by SUN NUCLEAR CORP.

• 05060608881192 - SunSILICON: 2025-07-16The SunSILICON detector is intended for use as a relative dosimetry detector in measurements of ionizing radiation emitted from a treatment delivery device.
• 05060608881192 - SunSILICON: 2025-07-16 The SunSILICON detector is intended for use as a relative dosimetry detector in measurements of ionizing radiation emitted from
• 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.