DEVICE: Iplan Rt Dose, Iplan Rt Adaptive, Iplan Rt Phantom Qa, Iplan Rt Review (04056481000592)
Device Identifier (DI) Information
Iplan Rt Dose, Iplan Rt Adaptive, Iplan Rt Phantom Qa, Iplan Rt Review
4.5
Not in Commercial Distribution
21381E
Brainlab AG
4.5
Not in Commercial Distribution
21381E
Brainlab AG
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
No | |
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. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
40887 | Radiation therapy software |
An application software program intended to facilitate/support the delivery of therapeutic radiation by enabling computer-assisted functionality in one or more of the following areas: treatment planning, simulation, record/verify, beam block CAD/CAM, quality assurance, and patient positioning. Some types may be combined with specific hardware or firmware accessories or configurations in order to function as intended.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MUJ | System,Planning,Radiation Therapy Treatment |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K080888 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
8a6e665e-d6ed-48a7-8ed7-1c61eeb685b1
January 31, 2023
4
September 15, 2016
January 31, 2023
4
September 15, 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 |
---|---|---|---|---|---|
No Package DIs found |
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
[?]
+49899915680
contact@brainlab.com
contact@brainlab.com