DEVICE: Tomosynthesis option (04056869001005)

Device Identifier (DI) Information

Tomosynthesis option
11104944
In Commercial Distribution

Siemens Healthcare GmbH
04056869001005
GS1

1
313217003 *Terms of Use
Option to the MAMMOMAT Inspiration FFDM system to acquire tomosynthesis images for mammography
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Device Characteristics

Labeling does not contain MRI Safety Information
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
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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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P140011 000
P140011 001
P140011 002
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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
No Device Sizes
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Device Record Status

8eb703a6-786b-464e-91f6-222b2930fbce
July 06, 2018
3
May 06, 2015
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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
No
No CLOSE

Customer Contact

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+1(800)888-7436
XX@XX.XX
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