Respiratory Gating for Scanners (RGSC)

GUDID 00856100006028

RGSC

Varian Medical Systems Imaging Laboratory GmbH

Real-time position management respiratory gating system, optical

• Primary Device ID: 00856100006028
• NIH Device Record Key: 440f823b-8e49-43a5-aed6-98c36bcbc85a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Respiratory Gating for Scanners (RGSC)
• Version Model Number: 1.1
• Company DUNS: 482243784
• Company Name: Varian Medical Systems Imaging Laboratory GmbH
• 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856100006028 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151533

FDA Product Code

• JAK: System, x-ray, tomography, computed

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: 2016-09-16

On-Brand Devices [Respiratory Gating for Scanners (RGSC)]

• 00856100006028: RGSC
• 00856100006196: 2.0