OARtrac

Basic Information

• Brand Name: OARtrac
• Primary DI: 00851546007080
• Version / Model: OT-CDU
• Catalog Number: OT-CDU
• Company Name: RADIADYNE, L.L.C.
• Labeler DUNS: 005744772
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 3a184f6f-9ff8-4456-a0b4-8cbbd3c07a21

Device Description

OARtrac Clinical Detector Unit (CDU) with its Charged Coupled Device (CCD) camera and the system’s own proprietary dose management software.

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: No
• 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
NZT	Dosimeter, Ionizing Radiation, Implanted	Radiology	892.5050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60320	MOSFET radiation therapy dosimetry system	An assembly of devices using metal oxide semiconductor field-effect transistor (MOSFET) technology intended to be used for on-the-spot patient or anthropomorphic radiation dose verification and monitoring during radiation therapy and radiology procedures. It typically consists of several wire-connected MOSFET dosimeters, a portable battery-powered dosimeter reader, and application software; it may include wireless data exchanging technology. Applications typically include radiation oncology therapy and dosimetry, treatment plan verification for in vivo dosimetry, brachytherapy, intraoperative radiation therapy, image-guided radiation therapy, and research.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00851546007080	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K141154	000