PlanIQ 1216028

GUDID 05060608880874

Radiation therapy QA software.

SUN NUCLEAR CORP.

Radiation therapy software Radiation therapy software Radiation therapy software Radiation therapy software Radiation therapy software Radiation therapy software Radiation therapy software Radiation therapy software Radiation therapy software Radiation therapy software Radiation therapy software Radiation therapy software

• Primary Device ID: 05060608880874
• NIH Device Record Key: 2491cb1e-e7d6-4a72-a662-3b345014db8e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PlanIQ
• Version Model Number: 1216028
• Catalog Number: 1216028
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060608880874 [Primary]
HIBCC	B016121600000 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142142

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: 2020-08-03
• Device Publish Date: 2020-07-24

On-Brand Devices [PlanIQ]

• B016121600000: Radiation therapy QA device.
• 05060608880874: Radiation therapy QA software.