FDA.reportPublic FDA data

ClariSIGMAM

Primary DI
08800046800013
Brand
ClariSIGMAM
Company
ClariPI Inc.
Model
1.1.7
Device description
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.
Published
2023-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
QIHAutomated Radiological Image Processing Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QIHAutomated Radiological Image Processing SoftwareRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203785000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203785000ClariSIGMAMClaripi, Inc.2021-09-10QIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800046800013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800046800013088000468000138800046800013

GMDN Terms#

Term, Definition table
TermDefinition
Radiology DICOM image processing application softwareA software application intended to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data; it is not intended for pathological image interpretation (i.e., not intended to detect and localize suspected abnormalities). It may be intended to facilitate image management (e.g., viewing, communication, printing, recording/ disc burning) and/or image manipulation and quantification (e.g., non-interpretive graphical overlays).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
693744312
Device count
1
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800046800259ClariPulmoClariPulmo Plus2025-06-25
08800046800150ClariPlatform1.02025-03-10
08800046800167ClariPlatformClariSuite View2025-03-10
08800046800228ClariCT.AIClariPET-CT2024-11-29
08800046800211ClariCT.AIClariCT.ACE2024-11-27
08800046800006ClariCT.AI1.1.02019-12-20
08800046800020ClariPulmo2.0.12023-08-31
08800046800136ClariCT.AI1.3.32023-08-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05745000308361Cercare Oncology Virtual Expert; CMN Capillary Function with Oncology Virtual ExCercare Medical A/SQIH2026-10-16
19356870000069PHA4DMEDICAL LIMITEDQIH2026-10-13
00198953083246VolusonGE Healthcare Austria GmbH & Co OGQIH2026-10-09
00198953083253VolusonGE Healthcare Austria GmbH & Co OGQIH2026-10-09
00198953083260VolusonGE Healthcare Austria GmbH & Co OGQIH2026-10-09
00198953200421EchoPACGE Vingmed Ultrasound A/SQIH2026-10-07
00198953200438EchoPACGE Vingmed Ultrasound A/SQIH2026-10-07
04262352357645DS Core DiagnosisZetta25 AGQIH2026-10-06
00860006442651cmAngioCuremetrix, Inc.QIH2026-10-05
08809887550170EdgeFlow UH10CEdgeCare Inc.QIH2026-09-30
08809887550187EdgeFlow UH10EEdgeCare Inc.QIH2026-09-30
00195278985613NAGE Medical Systems (China) Co.,Ltd.QIH2026-09-24
00198953126073VividGE Vingmed Ultrasound A/SQIH2026-09-21
00198953172384VividGE Vingmed Ultrasound A/SQIH2026-09-21
00198953172551VividGE Vingmed Ultrasound A/SQIH2026-09-21
00884838128095Affiniti 50 Diagnostic Ultrasound SystemPhilips Ultrasound LLCQIH2026-09-18
00884838128101Affiniti 70 Diagnostic Ultrasound SystemPhilips Ultrasound LLCQIH2026-09-18
00884838128118Affiniti 30 Diagnostic Ultrasound SystemPhilips Ultrasound LLCQIH2026-09-18
00884838128125EPIQ Elite Diagnostic Ultrasound SystemPhilips Ultrasound LLCQIH2026-09-18
08437021722109ADAS 3DADAS3D MEDICAL S.L.QIH2026-09-18
B720BX360HYPERDENSI1440Brainomix 360 HyperdensityBRAINOMIX LIMITEDQIH2026-09-18
00860016420922AI-CVDHeart Lung CorporationQIH2026-09-04
04262352350059DS Core CBCT AnatomyZetta25 AGQIH2026-08-26
00884838129924AV Cardiovascular Suite V1Philips Medical Systems Nederland B.V.QIH2026-08-23
08800357291937V6 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.QIH2026-08-18
08800357300165V7 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.QIH2026-08-18
08800357308208V8 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.QIH2026-08-18
00860006305734See-Mode TechnologiesSEE-MODE TECHNOLOGIES PTE. LTD.QIH2026-08-07
04068151012453syngo.CT Coronary CockpitSiemens Healthcare GmbHQIH2026-07-17
04068151034202syngo DynamicsSiemens Healthineers AGQIH2026-07-16