DEVICE: ASPIRE Cristalle (04547410297546)

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Device Identifier (DI) Information

ASPIRE Cristalle
DR 3500 W 24X30 USA + E

FUJIFILM CORPORATION
04547410297546
GS1
1
The Fujifilm Digital Mammography Systems, ASPIRE Cristalle (FDR MS-3500) generates full-field digital mammography images that can, as other full-field digital mammography systems, be used for screening and diagnosis of breast cancer and is intended for use in the same clinical applications as traditional screen-film mammography systems.
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Device Characteristics

Labeling does not contain MRI Safety Information
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
Stationary mammographic x-ray system, digital An assembly of devices specifically designed to provide a fixed installation (in an imaging facility, or transportation van) x-ray system to compress and image the breast. A digital mammography system (DMS) is used to record the absorption pattern of x-ray beams passed through the breast onto various image archive media, e.g., film, paper, digital/video formats. It is used to optimize the capability of users to visually evaluate the anatomy and function of blood and lymphatic vessels within the breast. It uses digital techniques for image capture and display. A DMS is used for breast cancer screening and for the placement of, e.g., biopsy markers or stereotactic biopsy.
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FDA Product Code

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Product Code Product Code Name
MUE Full field digital,system,x-ray,mammographic
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Sterilization

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

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Storage and Handling
Storage Environment Humidity: between 10 and 80 Percent (%) Relative Humidity
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Handling Environment Temperature: between 20 and 30 Degrees Celsius
Handling Environment Atmospheric Pressure: between 75 and 106 KiloPascal
Storage Environment Atmospheric Pressure: between 75 and 106 KiloPascal
Storage Environment Temperature: between 15 and 35 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
September 16, 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
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No CLOSE

Customer Contact

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+018002728465
xxx@xxx.xxx
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