PlanIQ 12160000

GUDID B016121600000

Radiation therapy QA device.

SUN NUCLEAR CORP.

Radiation therapy software

• Primary Device ID: B016121600000
• NIH Device Record Key: 53ae3469-678a-4ebf-90c3-c75d0435d1ed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PlanIQ
• Version Model Number: 12160000
• Catalog Number: 12160000
• 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
HIBCC	B016121600000 [Primary]

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-01-14

On-Brand Devices [PlanIQ]

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