HeadSTEP IMRT Basic Module

Basic Information

• Brand Name: HeadSTEP IMRT Basic Module
• Primary DI: 09120074394124
• Version / Model: P10107-412
• Company Name: IT-V Medizintechnik GmbH
• Labeler DUNS: 300005408
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-01
• Public Version: 5
• Public Version Date: 2019-05-23
• Public Version Status: Update
• Public Device Record Key: 76eac206-f9da-4b9b-8ecb-8b53baaac131

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IYE	Accelerator, Linear, Medical	Radiology	892.5050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40902	Radiological whole-body positioner	A device comprised of fixed or adjustable position elements designed to ensure adequate positioning and/or immobilization of a patient's whole body during diagnostic imaging, image guided surgical or interventional procedures, and/or radiation therapy procedures; it may in addition be used to position a patient’s body part (however it is not dedicated to a specific part of the body). It is in the form of a frame, board, cushion, or preformed pad and may be used to facilitate reproducible positioning for serial imaging studies or serial radiation therapy treatments.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09120074394124	GS1

Premarket Submissions

Submission Number	Supplement Number
K081218	000