DEVICE: ASPIRE Cristalle Digital Breast Tomosynthesis Option (04547410351316)

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Device Identifier (DI) Information

ASPIRE Cristalle Digital Breast Tomosynthesis Option
DR 3500 TOMO KIT V2.0 USA E

FUJIFILM CORPORATION
04547410351316
GS1
1
The Fujifilm ASPIRE Cristalle with Digital Breast Tomosynthesis (DBT) Option acquires and generates FFDM and DBT images.
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Device Characteristics

Labeling does not contain MRI Safety Information
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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 A stationary assembly of devices designed to generate x-ray images of the breast using digital techniques for image capture and display. It is designed specifically to compress the breast during imaging and is intended to visually evaluate the anatomy and function of blood and lymphatic vessels within the breast. Often referred to as a digital mammography system (DMS) it is typically used for breast cancer screening or during biopsy procedures (e.g., placement of biopsy markers, stereotactic biopsy). It is designed to capture two-dimensional (2-D) x-ray images, however may include software intended to process multiple images to create a three-dimensional (3-D) image/model (tomosynthesis).
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FDA Product Code

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Product Code Product Code Name
OTE Digital breast tomosynthesis
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Sterilization

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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
No Device Sizes
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Device Status

In Commercial Distribution
February 03, 2017

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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
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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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None
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Production Identifier(s) in UDI

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Customer Contact

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+018002728465
xxx@xxx.xxx
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