EDGE Dosimetry Detector (BNC) 11180000Z

GUDID B01611180000Z0

Radiation therapy QA device.

SUN NUCLEAR CORP.

Solid-state-semiconductor radiation measuring probe

• Primary Device ID: B01611180000Z0
• NIH Device Record Key: 4b7eb491-8353-40c4-8d83-f873b952cc33
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EDGE Dosimetry Detector (BNC)
• Version Model Number: 11180000Z
• Catalog Number: 11180000Z
• 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 *Store where the detector will not be irradiated by the direct beam and where scattered radiation will be kept at a minimum.
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store where the detector will not be irradiated by the direct beam and where scattered radiation will be kept at a minimum.
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B01611180000Z0 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-01-14

Devices Manufactured by SUN NUCLEAR CORP.

• 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.
• 05060608880102 - StereoPHAN: 2020-07-31 Radiation therapy, machine QA device
• 05060608880751 - IC PROFILER: 2020-07-31 Radiation therapy QA device.
• 05060608880768 - IC PROFILER-MR: 2020-07-31 Radiation therapy QA device.