DEVICE: SagiPlan® with prostate module (04065983000047)
Device Identifier (DI) Information
SagiPlan® with prostate module
06
In Commercial Distribution
1374-0610
BEBIG Medical GmbH
06
In Commercial Distribution
1374-0610
BEBIG Medical GmbH
SagiPlan® is a Brachytherapy Treatment Planning System used by medical professionals. SagiPlan® is used for the creation of treatment plans for remote afterloader based HDR brachytherapy.
SagiPlan® will calculate a proposed treatment course based on imported clinical images and other user entered data. SagiPlan® also supports the evaluation of clinical images in calculating the dose for organs at risk and target volumes. SagiPlan® especially supports the SagiNova (Multisource and GyneSource) Brachytherapy Remote Controlled Afterloading Devices from BEBIG Medical GmbH (Eckert & Ziegler BEBIG GmbH).
Device Characteristics
Labeling does not contain MRI Safety Information | |
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Yes | |
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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? |
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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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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MUJ | System, Planning, Radiation Therapy Treatment |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K141900 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Handling Environment Temperature: between 10 and 35 Degrees Celsius |
Handling Environment Humidity: between 20 and 80 Percent (%) Relative Humidity |
Storage Environment Temperature: between -40 and 65 Degrees Celsius |
Storage Environment Humidity: between 5 and 95 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
eaee6bbb-9615-492d-a8b8-50a6cc9b6002
December 06, 2023
1
November 28, 2023
December 06, 2023
1
November 28, 2023
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
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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