VeriSuite

GUDID 04260308110023

MedCom Gesellschaft für medizinische Bildverarbeitung mbH

Radiation therapy software

• Primary Device ID: 04260308110023
• NIH Device Record Key: 0eba3536-d27a-49fb-b309-671317b1af8d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VeriSuite
• Version Model Number: 1.8
• 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: true
• 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	04260308110023 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133914

FDA Product Code

• LHN: System, Radiation Therapy, Charged-Particle, 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: 4
• Public Version Date: 2019-10-24
• Device Publish Date: 2016-09-24

Devices Manufactured by MedCom Gesellschaft für medizinische Bildverarbeitung mbH

• 04260308110092 - Prelude: 2022-10-13 The Prelude software supports radiation therapy workflows for IntraOp Mobetron, a radiation treatment device. It assists to find
• 04260308110108 - Prelude: 2022-10-13 The Prelude software supports radiation therapy workflows for IntraOp Mobetron, a radiation treatment device. It assists to find
• 04260308110023 - VeriSuite: 2019-10-24
• 04260308110023 - VeriSuite: 2019-10-24