HeadSTEP IMRT MR Basic Module

GUDID 09120074394018

IT-V Medizintechnik GmbH

Head/neck procedure positioner

• Primary Device ID: 09120074394018
• NIH Device Record Key: d562976c-6c83-42db-8d1a-ae555353b432
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HeadSTEP IMRT MR Basic Module
• Version Model Number: P10107-401
• Company DUNS: 300005408
• Company Name: IT-V Medizintechnik GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• 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	09120074394018 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081218

FDA Product Code

• IYE: Accelerator, Linear, Medical

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: 2024-11-20
• Device Publish Date: 2024-11-12

Devices Manufactured by IT-V Medizintechnik GmbH

• 09120074395176 - HS S-TYPE Basic Module MR: 2026-03-18
• 09120074397194 - System HS S-TYPE MR: 2026-03-18
• 09120074394490 - HS Bite Angulating Fixation Set Wide: 2026-03-10
• 09120074397910 - System HeadSTEP Bite Wide: 2026-03-10
• 09120074396364 - Wall holder for CT STEP: 2026-02-12
• 09120074394018 - HeadSTEP IMRT MR Basic Module: 2024-11-20
• 09120074394018 - HeadSTEP IMRT MR Basic Module: 2024-11-20
• 09120074395312 - WingSTEP high for Varian Baseplate: 2024-11-20
• 09120074395329 - WingSTEP low for Varian Baseplate: 2024-11-20