DEVICE: Extend Frame system (07340048305327)
Device Identifier (DI) Information
Extend Frame system
1526879
In Commercial Distribution
Elekta Instrument AB
1526879
In Commercial Distribution
Elekta Instrument AB
DIM ZHERMACK (1PCS)
Device Characteristics
MR Unsafe | |
No | |
No | |
Yes | |
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? |
---|---|---|---|---|
38297 | Teletherapy radionuclide system, conventional |
A stationary assembly of computer-based devices designed to deliver a therapeutic radiation dose to an anatomical region from a single external radiation beam produced by a radionuclide source, typically to treat malignant tumours; it does not provide image-guided radiation therapy (IGRT) functionality during treatment delivery. A typical system is: 1) the treatment head (a shielded source vault containing a single radioactive source); 2) a rotating or fixed gantry with the treatment head; 3) a collimator mechanism attached to the gantry to align the treatment beam; 4) a moveable patient table; and 5) an operator's console with controls. It is commonly known as a cobalt therapy machine.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
IWB | System, radiation therapy, radionuclide |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K092083 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 5 and 27 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
2a5b7ddb-24c2-448c-9eb3-a5cd27e8fa16
November 14, 2022
5
September 24, 2016
November 14, 2022
5
September 24, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
07340048304597 | 2 | 07340048305327 | In Commercial Distribution |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
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
[?]
+1(855)693-5358
info.america@elekta.com
info.america@elekta.com