DEVICE: iReveal Breast Density Assessment (00858012005205)

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Device Identifier (DI) Information

iReveal Breast Density Assessment
V2.1
D70124, D70141 and D70126
Icad, Inc.
00858012005205
GS1
1
iReveal Breast Density is a software application intended for use with digital mammography systems. iReveal Breast Density calculates breast density as a ratio of fibroglandular tissue and total breast area estimates. iReveal Breast Density provides these numerical values for each breast as well as a density category to aid radiologists in the assessment of breast tissue composition. iReveal Breast Density produces adjunctive information. It is not an interpretive or diagnostic aid.
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Device Characteristics

Labeling does not contain MRI Safety Information
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No
No
Yes
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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
Basic diagnostic x-ray system application software An individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a general-purpose x-ray imaging system configuration. A basic set of applications programs and routines are included with such computer-controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some applications software routines or groups of routine packages must be combined with specific hardware or firmware accessories or configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.
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FDA Product Code

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Product Code Product Code Name
LLZ System, Image Processing, Radiological
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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 Status

In Commercial Distribution
September 23, 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
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None
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Production Identifier(s) in UDI

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No
Yes
No
Yes
No CLOSE

Customer Contact

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866-280-2239
support@icadmed.com
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