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
OTC
false
Sterile
false
Single use
false

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
Radiological PACS-dedicated management softwareA software program dedicated for installation on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of a broad range of radiological images throughout the healthcare system. As a PACS-dedicated software, it is not primarily intended for diagnosis support, triage, or treatment planning. It does not incorporate adaptive/dynamic machine learning (ML) models.

Contacts#

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

Regulatory Flags#

DUNS number
108968505
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00850012642121Unfold AIAvenda Health, Inc.POK2026-08-19
00860012425303RevealAI-LungPrecision Medical Ventures Inc.POK2026-05-29
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
B761R60RapidIschemaview, 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