Head Coil (Receive Only)

Basic Information

• Brand Name: Head Coil (Receive Only)
• Primary DI: 00868029000391
• Version / Model: 23820
• Company Name: VIEWRAY INCORPORATED
• Labeler DUNS: 015705677
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-05-06
• Public Version: 1
• Public Version Date: 2022-05-16
• Public Version Status: New
• Public Device Record Key: 7e87b65d-c1f8-4c60-aaa5-5bc7c7235ffe

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: MR Safe
• 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
KNH	Laparoscopic Contraceptive Tubal Occlusion Device	Obstetrics/Gynecology	884.5380	3

GMDN Terms

Code	Name	Definition	Implantable	Status
35159	Linear accelerator system	An assembly of devices designed to produce high-energy electrons to yield high-energy x-rays used for therapeutic applications, primarily to treat cancer. It provides a uniform radiation field of uniform intensity and predictable energy level, in a beam with well defined dimensions. The principle of operation is linear acceleration of electrons by means of electromagnetic (EM) microwaves. The output is used as a treatment beam on the patient, either directly or after passing a suitable target. The system typically includes signal analysis and display devices, patient and device supports, and software.	No	Active
62147	Stereotactic teletherapy radionuclide system, MRI-imaging	A stationary assembly of computer-based devices designed to simultaneously create magnetic resonance imaging (MRI) images and deliver gamma radiation from a radionuclide source (typically cobalt) for stereotactic-radiosurgical therapy, typically to treat malignant tumours; the MRI images can be used to monitor treatment in real-time. It consists of radiation-emitting heads and collimators in a rotating gantry assembly; a magnet MRI system for soft-tissue imaging; patient couch and integrated positioning system; control consoles for image acquisition, planning and treatment administration; and integrated software.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00868029000391	GS1

Premarket Submissions

Submission Number	Supplement Number
K212958	000