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
04056481000592
GS1
June 14, 2017
1
314482980 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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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FDA Product Code

[?]
Product Code Product Code Name
MUJ System,Planning,Radiation Therapy Treatment
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K080888 000
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

8a6e665e-d6ed-48a7-8ed7-1c61eeb685b1
July 06, 2018
3
September 15, 2016
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+49899915680
contact@brainlab.com
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