DEVICE: KermaX-plus (EIBA1201320)
Device Identifier (DI) Information
KermaX-plus
1
In Commercial Distribution
120-132
IBA Dosimetry GmbH
1
In Commercial Distribution
120-132
IBA Dosimetry GmbH
KermaX Product family is designed to be installed in diagnostic x-ray units and is intended to be used for the measurement of Dose Area Product (DAP)/ DAP rate, exposure time.
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. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
38385 | Diagnostic x-ray system quality assurance device |
An instrument intended to be used to assess the performance of diagnostic x-ray equipment for quality assurance (QA) purposes; it is typically intended to measure, display, and record one or more x-ray parameter(s) [e.g., kVp, mAs, dose, exposure time]. It may be placed in the field of view and/or be connected to the x-ray equipment, and may have various forms (e.g., handheld or desktop unit with sensor and dedicated software).
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LHO | Instrument, Quality-Assurance, Radiologic |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
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
792a0d83-98bf-4eb0-8f63-d3750fa25253
July 04, 2022
2
December 17, 2021
July 04, 2022
2
December 17, 2021
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
EIBA1201321 | 1 | EIBA1201320 | In Commercial Distribution |
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
[?]
+1 786 288 0369
service-usa@iba-group.com +6531292472
service-apac@iba-group.com +49912860738
service-emea@iba-group.com
service-usa@iba-group.com +6531292472
service-apac@iba-group.com +49912860738
service-emea@iba-group.com