Raypilot Receiver

Basic Information

• Brand Name: Raypilot Receiver
• Primary DI: 07350007952202
• Version / Model: 1
• Catalog Number: 2020
• Company Name: Micropos Medical AB (Publ)
• Labeler DUNS: 350533316
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-03-12
• Public Version: 1
• Public Version Date: 2025-03-20
• Public Version Status: New
• Public Device Record Key: 73937b02-a432-44b0-b5e6-14b8e49c22af

Device Description

Raypilot Receiver is a part of Raypilot System for realtime monitoring of a target during radiation therapy

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: Yes
• 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
46467	Radiation therapy invasive marker lesion localization system	An assembly of noninvasive devices intended to monitor the position of a patient's tumour/lesion relative to the isocenter of a radiation therapy system, to assist with their alignment during treatment planning or a therapeutic procedure. It localizes the position of invasive markers [e.g., electromagnetic (EM) signal transmitters, radiopaque markers] (not included) which have been introduced/implanted in or near the target site prior to treatment. It typically includes an EM receiver and dedicated software.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07350007952202	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K203722	000