DEVICE: Phantom (B214OSPTM3)

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Device Identifier (DI) Information
Phantom
3
In Commercial Distribution

medimaps group SA
B214OSPTM3
HIBCC

1
486330728 *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© 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?
40626 Bone densitometry ultrasound phantom, test object
A device that consists of a uniform density or a two or three-dimensional (3-D) pattern of objects, materials, or openings of varying dimensions. It includes phantoms that come in both fixed and variable configurations and is a quality assurance (QA) device used in both subjective and quantitative evaluations of various calibration and performance characteristics of ultrasound bone density measurement systems (bone densitometers) and associated image acquisition, display, and analysis computer programs.
Active false
40622 Bone densitometry x-ray phantom, test object
A device that consist of a uniform density or a two or three-dimensional (3-D) pattern of objects, materials or openings of varying dimensions. It includes phantoms that come in both fixed and variable configurations. It is a quality assurance (QA) device used in both subjective and quantitative evaluations of various calibration and performance characteristics of x-ray based bone density measurement systems and associated image acquisition, display, and analysis computer programs.
Active false
40628 Diagnostic ultrasound phantom, test object
A device that consists of a uniform density or a two or three-dimensional (3-D) pattern of objects, materials, or openings of varying dimensions. It includes phantoms that come in both fixed and variable configurations. It is a quality assurance (QA) device that enables both subjective and quantitative evaluations of various calibration and performance characteristics of diagnostic ultrasound systems and associated image acquisition, display, and analysis computer programs.
Active false
40603 CT phantom, test object
A device that consist of a uniform density or a two or three-dimensional (3-D) pattern of objects, materials or openings of varying dimensions that comes in both fixed and variable configurations. It is a quality assurance (QA) device used in both subjective and quantitative evaluations of various calibration and performance characteristics of diagnostic x-ray computed tomography (CT) imaging systems and associated image acquisition, display, and analysis computer programs.
Active false
40614 General-purpose diagnostic x-ray phantom, test object
A device that consists of a uniform density or a two or three-dimensional (3-D) pattern of objects, materials or openings of varying dimensions. It includes phantoms that come in both fixed and variable configurations. It is a quality assurance (QA) device used in both calibration protocols and in subjective and quantitative evaluations of various calibration and performance characteristics of conventional and digital general-purpose x-ray imaging systems. It is also used in the assessment of the performance characteristics of associated image acquisition, display, and analysis computer programs.
Active false
40616 Multi-modality diagnostic imaging phantom, test object
A device that consists of a uniform density or a two or three-dimensional (3-D) pattern of objects, materials or openings of varying dimensions. It includes phantoms that come in both fixed and variable configurations and is a quality assurance device used in both subjective and quantitative evaluations of various calibration and performance characteristics of diagnostic imaging systems. A multi-modality phantom is specifically intended for use with more than one diagnostic imaging modality, e.g., magnetic resonance imaging (MRI), ultrasound, x-ray and nuclear medicine (NM) systems.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
KGI Densitometer, Bone
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes 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
6da5bd10-c978-43db-91af-e1c7d53b0bf8
October 04, 2023
2
December 08, 2022
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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
Yes
No
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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