FDA.reportPublic FDA data

QuantX

Primary DI
B80711
Brand
QuantX
Company
QLARITY IMAGING, LLC
Model
Breast MRI
Catalog number
1
Device description
QuantX is a software program that analyzes patient breast images, and is designed to aid radiologists in the characterization of lesions as part of high-risk screening or diagnostic work-up.
Published
2020-02-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
POKComputer-Assisted Diagnostic Software For Lesions Suspicious For Cancer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
POKComputer-Assisted Diagnostic Software For Lesions Suspicious For CancerRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN170022000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN170022000QuantXQuantitative Insights, Inc.2017-07-19POK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B80711PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Radiology PACS softwareAn individual software application intended to be installed on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of radiological images. It is designed specifically for use within radiology.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
312-847-1627mjohnston@qlarityimaging.com
312-847-1622mharrison@qlarityimaging.com

Regulatory Flags#

DUNS number
108968505
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B80721QuantXBreast MRI Biopsy Guidance Plugin22020-02-27
B80731QuantXBreast MRI SE32020-02-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B720BX360EASPECTS1430e-ASPECTSBRAINOMIX LIMITEDPOK2026-05-06
00198953100509Automated Aortic StenosisGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCPOK2026-05-05
B720BX360EASPECTS1210Brainomix e-ASPECTSBRAINOMIX LIMITEDPOK2026-03-30
00850012642114Unfold AIAvenda Health, Inc.POK2026-03-06
G762AISAPCARDIOV10AISAP Cardio V1.0AISAP LTDPOK2026-02-18
B720BX360EASPECTS1420e-ASPECTSBRAINOMIX LIMITEDPOK2026-02-03
00850012642107Unfold AIAvenda Health, Inc.POK2025-11-24
B720BX360EASPECTS1200e-ASPECTSBRAINOMIX LIMITEDPOK2025-10-15
B720BX360EASPECTS1410e-ASPECTSBRAINOMIX LIMITEDPOK2025-10-13
03760415600048B-Right Screen Fetal HeartBRIGHTHEARTPOK2025-10-13
00850012642091Unfold AIAvenda Health, Inc.POK2025-09-29
03770024341034Sonio SuspectSONIOPOK2025-09-03
B720BX360EASPECTS1400e-ASPECTSBRAINOMIX LIMITEDPOK2025-08-18
B761R60Rapid Ischemaview, Inc.POK2025-05-07
B720BX360EASPECTS113e-ASPECTSBRAINOMIX LIMITEDPOK2025-04-15
00850012642084Unfold AIAvenda Health, Inc.POK2025-03-31
00850012642077Unfold AIAvenda Health, Inc.POK2025-03-17
00850012642060Unfold AIAvenda Health, Inc.POK2025-02-12
00882916001025StrokeSENS LVOCircle Cardiovascular Imaging IncPOK2025-02-05
03760415600000B-Right Screen Fetal HeartBRIGHTHEARTPOK2025-01-28
00850012642053Unfold AIAvenda Health, Inc.POK2024-11-20
09309001128005EchoSolv ASECHOIQ LIMITEDPOK2024-11-14
00850012642046Unfold AIAvenda Health, Inc.POK2024-09-18
00850012642039Unfold AIAvenda Health, Inc.POK2024-05-07
B826CINAASPECTS150CINA-ASPECTSAVICENNA.AIPOK2024-03-29
B761R5711RapidIschemaview, Inc.POK2024-02-13
B761R5721RapidIschemaview, Inc.POK2024-02-13
B761R610RapidIschemaview, Inc.POK2024-02-13
00850012642022Unfold AIAvenda Health, Inc.POK2023-12-18
B761R5701RapidIschemaview, Inc.POK2023-06-29