HexaPOD P10603-100

GUDID 04056719001698

HexaPOD™ evo Module is a robotic couch top which fine adjusts the tumour position to the ISO center

Medical Intelligence Medizintechnik GmbH

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• Primary Device ID: 04056719001698
• NIH Device Record Key: b3ab27a9-f942-497d-8128-a8640f0a1be5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HexaPOD
• Version Model Number: P10603-100
• Catalog Number: P10603-100
• Company DUNS: 314546664
• Company Name: Medical Intelligence Medizintechnik 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04056719001698 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072898

FDA Product Code

• JAI: Couch, Radiation Therapy, Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-08-23

On-Brand Devices [HexaPOD]

• 04056719001711: HexaPOD™ evo PowerBox supplies the electrical power and interfaces between the components
• 04056719001698: HexaPOD™ evo Module is a robotic couch top which fine adjusts the tumour position to the ISO c
• 04056719001681: HexaPOD™ Enable Switch Board enables the HexaPOD™ evo Module to execute a movement command
• 04056719001667: HexaPOD Handheld Controller for manual movement of HexaPOD evo module
• 04056719002244: HexaPOD one Module is a robotic couch top which fine adjusts the tumour position to the ISO cent