DEVICE: SoloMobile (05711665004009)
Device Identifier (DI) Information
SoloMobile
SoloMobile Gamma Camera System
In Commercial Distribution
9SOL2210
Ddd-Diagnostic A/S
SoloMobile Gamma Camera System
In Commercial Distribution
9SOL2210
Ddd-Diagnostic A/S
Gamma Camera System
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. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
40641 | 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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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
IYX | Camera, Scintillation (Gamma) |
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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Weight: 252 Kilogram |
Height: 173 Centimeter |
Depth: 138 Centimeter |
Width: 70 Centimeter |
Device Record Status
0d4dd789-23e1-4e4e-8e86-0ae1cd5ca72e
March 29, 2018
2
November 15, 2016
March 29, 2018
2
November 15, 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
[?]
9999999999
support@ddd-diagnostic.dk
support@ddd-diagnostic.dk