DEVICE: ProBeam Proton Therapy System (00858991006019)
Device Identifier (DI) Information
ProBeam Proton Therapy System
3.0
In Commercial Distribution
Varian Medical Systems Particle Therapy GmbH & Co. KG
3.0
In Commercial Distribution
Varian Medical Systems Particle Therapy GmbH & Co. KG
Fixed Beam
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
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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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47069 | Proton therapy system |
An assembly of devices/sub-systems designed to produce and deliver a transverse- and longitudinal-dose proton beam to treat localized tumours and other conditions susceptible to treatment by radiation. It typically consists of components for beam production, transport and delivery; patient positioning; system and component control; and software. It will typically be configured to a particular site’s requirements.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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LHN | System, radiation therapy, charged-particle, medical |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K133191 | 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
ec8997c5-d39f-4e0b-acac-3ddbaf75aaeb
November 03, 2023
4
September 21, 2016
November 03, 2023
4
September 21, 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