DEVICE: Biograph mCT X-4R (04056869001364)
Device Identifier (DI) Information
Biograph mCT X-4R
10248670
In Commercial Distribution
SIEMENS MEDICAL SOLUTIONS USA, INC.
10248670
In Commercial Distribution
SIEMENS MEDICAL SOLUTIONS USA, INC.
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
PET/CT system | A diagnostic radiological imaging system that is a combination of a positron emission tomography (PET) camera system for nuclear medicine (NM) images, and a computed tomography (CT) camera system for x-ray images. The nuclear medicine images and the x-ray images may be registered and displayed in a fused format (overlaid in the same orientation) for the anatomical localization of the nuclear medicine data (i.e., distribution of radiopharmaceuticals). The PET and CT portions of the system may be used independently or in combination. The PET and CT images may be transferred to other systems for radiation therapy planning or additional processing. |
FDA Product Code
[?]Product Code | Product Code Name |
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KPS | System, tomography, computed, emission |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal |
Storage Environment Temperature: between 10 and 30 Degrees Celsius |
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal |
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity |
Handling Environment Temperature: between -20 and 50 Degrees Celsius |
Storage Environment Humidity: between 20 and 75 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
d0c8884e-83f4-4e4f-a010-571e79f97934
March 29, 2018
2
September 24, 2016
March 29, 2018
2
September 24, 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
[?]
+1(800)888-7436
XX@XX.XX
XX@XX.XX