QuantX 2

GUDID B80721

The QuantX Breast MRI Biopsy Guidance Plugin is a software application that assists users of the QuantX software device in planning MRI guided interventional procedures.

QLARITY IMAGING, LLC

Radiology PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software
Primary Device IDB80721
NIH Device Record Key1d8dfe1b-e660-4e85-9707-b3de7015e088
Commercial Distribution StatusIn Commercial Distribution
Brand NameQuantX
Version Model NumberBreast MRI Biopsy Guidance Plugin
Catalog Number2
Company DUNS108968505
Company NameQLARITY IMAGING, LLC
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 Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone312-847-1627
Emailmjohnston@qlarityimaging.com
Phone312-847-1627
Emailmjohnston@qlarityimaging.com
Phone312-847-1627
Emailmjohnston@qlarityimaging.com
Phone312-847-1627
Emailmjohnston@qlarityimaging.com
Phone312-847-1627
Emailmjohnston@qlarityimaging.com
Phone312-847-1627
Emailmjohnston@qlarityimaging.com
Phone312-847-1627
Emailmjohnston@qlarityimaging.com
Phone312-847-1627
Emailmjohnston@qlarityimaging.com
Phone312-847-1627
Emailmjohnston@qlarityimaging.com
Phone312-847-1627
Emailmjohnston@qlarityimaging.com
Phone312-847-1627
Emailmjohnston@qlarityimaging.com
Phone312-847-1627
Emailmjohnston@qlarityimaging.com
Phone312-847-1627
Emailmjohnston@qlarityimaging.com
Phone312-847-1627
Emailmjohnston@qlarityimaging.com
Phone312-847-1627
Emailmjohnston@qlarityimaging.com
Phone312-847-1627
Emailmjohnston@qlarityimaging.com
Phone312-847-1627
Emailmjohnston@qlarityimaging.com
Phone312-847-1627
Emailmjohnston@qlarityimaging.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB80721 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLZSystem, Image Processing, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-06
Device Publish Date2020-02-27

On-Brand Devices [QuantX]

B80731QuantX is a software program that is used to view and analyze patient breast images.
B80711QuantX is a software program that analyzes patient breast images, and is designed to aid radiolo
B80721The QuantX Breast MRI Biopsy Guidance Plugin is a software application that assists users of the

Trademark Results [QuantX]

Mark Image

Registration | Serial
Company
Trademark
Application Date
QUANTX
QUANTX
87137603 not registered Live/Pending
Micron Technology, Inc.
2016-08-13
QUANTX
QUANTX
87104547 5188464 Live/Registered
Blue Sky Asset Management LLC
2016-07-14
QUANTX
QUANTX
85090864 4218366 Live/Registered
I & J Fisnar, Inc.
2010-07-22
QUANTX
QUANTX
75928850 not registered Dead/Abandoned
Advanced Cardiovascular Systems, Inc.
2000-02-26
QUANTX
QUANTX
75914132 not registered Dead/Abandoned
QuantX, Inc.
2000-01-12
QUANTX
QUANTX
75372074 not registered Dead/Abandoned
Ontogeny, Inc.
1997-10-14
QUANTX
QUANTX
75372073 not registered Dead/Abandoned
Ontogeny, Inc.
1997-10-14
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