Prelude

GUDID 04260308110092

The Prelude software supports radiation therapy workflows for IntraOp Mobetron, a radiation treatment device. It assists to find product specific machine parameters for treatment and can send those proposals to the console of the device. The machine parameters are not intended to be used for direct control for the radiation device.

MedCom Gesellschaft für medizinische Bildverarbeitung mbH

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• Primary Device ID: 04260308110092
• NIH Device Record Key: 38453097-0d00-435d-9e0b-c0c14d42e5e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prelude
• Version Model Number: V1. IORT
• Company DUNS: 537689275
• Company Name: MedCom Gesellschaft für medizinische Bildverarbeitung mbH
• 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: false
• 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	04260308110078 [Previous]
GS1	04260308110092 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180308

FDA Product Code

• MUJ: System, Planning, Radiation Therapy Treatment

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: 2022-10-13
• Device Publish Date: 2022-10-05

On-Brand Devices [Prelude ]

• 04260308110108: The Prelude software supports radiation therapy workflows for IntraOp Mobetron, a radiation trea
• 04260308110092: The Prelude software supports radiation therapy workflows for IntraOp Mobetron, a radiation trea