iGUIDE® P10603-111

GUDID 04056719002190

iGUIDE® is the control software of the HexaPOD™ evo RT Couchtop. Software Revison 2.2.3 includes security patch.

Medical Intelligence Medizintechnik GmbH

Accelerator system table, powered

• Primary Device ID: 04056719002190
• NIH Device Record Key: 9cb7d39f-92a1-4c42-b3ce-bb713cc58a5f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iGUIDE®
• Version Model Number: P10603-111-223
• Catalog Number: P10603-111
• 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: true
• Serial Number: false
• 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	04056719002190 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143485

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: 2
• Public Version Date: 2021-10-13
• Device Publish Date: 2019-08-01

Devices Manufactured by Medical Intelligence Medizintechnik GmbH

• 04056719002251 - iBEAM: 2022-07-20 iBEAM® evo Couchtop EH is intended to support the patient during radiation therapy or radiation therapy simulation. iBEAM® evo
• 04056719002190 - iGUIDE®: 2021-10-13iGUIDE® is the control software of the HexaPOD™ evo RT Couchtop. Software Revison 2.2.3 includes security patch.
• 04056719002190 - iGUIDE®: 2021-10-13 iGUIDE® is the control software of the HexaPOD™ evo RT Couchtop. Software Revison 2.2.3 includes security patch.
• 04056719002244 - HexaPOD: 2021-10-06 HexaPOD one Module is a robotic couch top which fine adjusts the tumour position to the ISO center
• 04056719002213 - iBEAM®: 2020-08-28 iBEAM® one Couchtop is intended to support the patient during radiation therapy or radiation therapy simulation.
• 04056719002237 - iBEAM®: 2020-07-15 iBEAM evo CT Overlay RT is intended to support the patient during CT and PET CT imaging procedures for radiation therapy applica
• 04056719002060 - Fraxion™: 2018-11-29 The Fraxion™ Thermoplastic Mask Head (10 pcs) is affixed to the Fraxion Headrest assuring safe immobilization and precise (re-
• 04056719002077 - Fraxion™: 2018-11-29 The Fraxion™ Thermoplastic Mask Nose (10pcs) is affixed to the Fraxion Headrest assuring safe immobilization and precise (re-)
• 04056719002084 - Fraxion™: 2018-11-29 The Fraxion™ Thermoplastic Mask Single Layer (10pcs) is affixed to the Fraxion Headrest assuring safe immobilization and preci