HeadSTEP MR Basic Module

GUDID 09120074394001

IT-V Medizintechnik GmbH

Radiological whole-body positioner

• Primary Device ID: 09120074394001
• NIH Device Record Key: 823b6304-b620-45bb-8c17-d22ba546dd85
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HeadSTEP MR Basic Module
• Version Model Number: P10107-400
• 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	09120074394001 [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: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2024-11-11
• Device Publish Date: 2016-09-01

Devices Manufactured by IT-V Medizintechnik GmbH

• 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
• 09120074395404 - BreastSTEP Short Mask Basic Module: 2024-11-20
• 09120074395411 - BreastSTEP Long Mask Basic Module: 2024-11-20
• 09120074395428 - BreastSTEP Short MR Basic Module: 2024-11-20
• 09120074395435 - BreastSTEP Long MR Basic Module: 2024-11-20
• 09120074391000 - HeadSTEP Carbon Basic Module: 2024-11-11