FDA.reportPublic FDA data

QuantX

Primary DI
B80731
Brand
QuantX
Company
QLARITY IMAGING, LLC
Model
Breast MRI SE
Catalog number
3
Device description
QuantX is a software program that is used to view and analyze patient breast images.
Published
2020-02-19
Public version status
Update
Distribution status
Not 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
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170195000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170195000QuantXQuantitative Insights, Inc.2017-05-17LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B80731PrimaryHIBCC0

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
B80711QuantXBreast MRI12020-02-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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B745ELUCIDB1P1Elucid Plaque-IQELUCID BIOIMAGING INC.LLZ2026-10-29
04719878712002OOOPDSTaiwan Main Orthopaedic Biotechnology Co., Ltd.LLZ2026-10-28
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