DEVICE: iGUIDE (04056719001704)
Device Identifier (DI) Information
iGUIDE
P10603-109
Not in Commercial Distribution
P10603-109
3C-Medical Intelligence GmbH
P10603-109
Not in Commercial Distribution
P10603-109
3C-Medical Intelligence GmbH
iGUIDE® Software 2.2 is the software which controls the movement of the the HexaPOD™ evo Module and monitors the correct position of the module
Device Characteristics
Labeling does not contain MRI Safety Information | |
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? |
---|---|---|---|---|
40687 | Accelerator system table, powered |
An electrically-powered and/or programmable radiotherapy device that is a component of an accelerator system specifically designed to position and support a patient, typically supine, during treatments administered using a medical linear accelerator or non-linear accelerator. It is a flat surface on legs that includes electronic and/or software controls for top height adjustments and positioning. It may be an independent device that is stationary or mobile, or it can be an integral component of a medical accelerator system design.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
IYE | Accelerator, Linear, Medical |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K143485 | 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
2afc8cff-aad4-4471-a6a0-b8007cb9c0e1
December 15, 2023
5
August 23, 2016
December 15, 2023
5
August 23, 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 |
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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