DEVICE: Head Coil (Receive Only) (00868029000391)
Device Identifier (DI) Information
Head Coil (Receive Only)
23820
In Commercial Distribution
VIEWRAY INCORPORATED
23820
In Commercial Distribution
VIEWRAY INCORPORATED
No description.
Device Characteristics
MR Safe | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
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.
|
Active | false |
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.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
IYE | Accelerator, Linear, Medical |
KNH | Laparoscopic Contraceptive Tubal Occlusion Device |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K212958 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
7e87b65d-c1f8-4c60-aaa5-5bc7c7235ffe
May 16, 2022
1
May 06, 2022
May 16, 2022
1
May 06, 2022
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined