DEVICE: SoloMobile (05711665004009)

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Device Identifier (DI) Information

SoloMobile
SoloMobile Gamma Camera System
9SOL2210
Ddd-Diagnostic A/S
05711665004009
GS1
1
Gamma Camera System
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Device Characteristics

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

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

GMDN Preferred Term Name GMDN Definition
Mobile gamma camera system An assembly of mobile diagnostic devices designed to record, quantify, and analyse radionuclide emissions (primarily gamma rays) produced during the decay of radiopharmaceuticals or other radiation emitting materials injected into, or ingested by, a patient. It uses Anger or non-Anger detection methods and consists of an analogue or digital detector based nuclear medicine (NM) planar imaging system, a sodium iodide (Nal) crystal(s), a collimator and a set of photomultiplier tubes. Gamma rays pass through holes in the collimator causing light flashes within the crystal corresponding to the sites of origin in the body and the amplitude of the flash is calculated by a computer to create images.
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FDA Product Code

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Product Code Product Code Name
IYX Camera, Scintillation (Gamma)
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Sterilization

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

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
Weight: 252 Kilogram
Height: 173 Centimeter
Depth: 138 Centimeter
Width: 70 Centimeter
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Device Status

In Commercial Distribution
November 15, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

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

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
Yes
No CLOSE

Customer Contact

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9999999999
support@ddd-diagnostic.dk
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