ClariSIGMAM

GUDID 08800046800013

ClariSIGMAM is a software application intended for use with compatible full field digital mammography systems. ClariSIGMAM calculates percent breast density defined as the ratio of fibroglandular tissue to total breast area estimates. ClariSIGMAM provides these numerical values along with breast density category in BI-RADS 5th Edition to aid radiologists in the assessment of breast tissue composition. ClariSIGMAM produces adjunctive information. It is not an interpretive or diagnostic aid.

ClariPI Inc.

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Primary Device ID08800046800013
NIH Device Record Key7b12f818-d08d-4f48-bbca-52d0ea495232
Commercial Distribution StatusIn Commercial Distribution
Brand NameClariSIGMAM
Version Model Number1.1.7
Company DUNS693744312
Company NameClariPI Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800046800013 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QIHAutomated Radiological Image Processing Software

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-08
Device Publish Date2023-08-31

Devices Manufactured by ClariPI Inc.

08800046800006 - ClariCT.AI2023-12-04
08800046800013 - ClariSIGMAM2023-09-08ClariSIGMAM is a software application intended for use with compatible full field digital mammography systems. ClariSIGMAM calculates percent breast density defined as the ratio of fibroglandular tissue to total breast area estimates. ClariSIGMAM provides these numerical values along with breast density category in BI-RADS 5th Edition to aid radiologists in the assessment of breast tissue composition. ClariSIGMAM produces adjunctive information. It is not an interpretive or diagnostic aid.
08800046800013 - ClariSIGMAM2023-09-08 ClariSIGMAM is a software application intended for use with compatible full field digital mammography systems. ClariSIGMAM calcu
08800046800020 - ClariPulmo2023-09-08 ClariPulmo is a non-invasive image analysis software for use with CT images which is intended to aid the assessment of lung Abno
08800046800136 - ClariCT.AI2023-09-06 ClariCT.AI, is a software device intended for networking, communication, processing and enhancement of CT images in DICOM format
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