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| Primary Device ID | B80721 |
| NIH Device Record Key | 1d8dfe1b-e660-4e85-9707-b3de7015e088 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | QuantX |
| Version Model Number | Breast MRI Biopsy Guidance Plugin |
| Catalog Number | 2 |
| Company DUNS | 108968505 |
| Company Name | QLARITY IMAGING, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 312-847-1627 |
| mjohnston@qlarityimaging.com | |
| Phone | 312-847-1627 |
| mjohnston@qlarityimaging.com | |
| Phone | 312-847-1627 |
| mjohnston@qlarityimaging.com | |
| Phone | 312-847-1627 |
| mjohnston@qlarityimaging.com | |
| Phone | 312-847-1627 |
| mjohnston@qlarityimaging.com | |
| Phone | 312-847-1627 |
| mjohnston@qlarityimaging.com | |
| Phone | 312-847-1627 |
| mjohnston@qlarityimaging.com | |
| Phone | 312-847-1627 |
| mjohnston@qlarityimaging.com | |
| Phone | 312-847-1627 |
| mjohnston@qlarityimaging.com | |
| Phone | 312-847-1627 |
| mjohnston@qlarityimaging.com | |
| Phone | 312-847-1627 |
| mjohnston@qlarityimaging.com | |
| Phone | 312-847-1627 |
| mjohnston@qlarityimaging.com | |
| Phone | 312-847-1627 |
| mjohnston@qlarityimaging.com | |
| Phone | 312-847-1627 |
| mjohnston@qlarityimaging.com | |
| Phone | 312-847-1627 |
| mjohnston@qlarityimaging.com | |
| Phone | 312-847-1627 |
| mjohnston@qlarityimaging.com | |
| Phone | 312-847-1627 |
| mjohnston@qlarityimaging.com | |
| Phone | 312-847-1627 |
| mjohnston@qlarityimaging.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B80721 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K191959
FDA Product Code
| LLZ | System, Image Processing, Radiological |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-03-06 |
| Device Publish Date | 2020-02-27 |
On-Brand Devices [QuantX]
| B80731 | QuantX is a software program that is used to view and analyze patient breast images. |
| B80711 | QuantX is a software program that analyzes patient breast images, and is designed to aid radiolo |
| B80721 | The 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 87137603 not registered Live/Pending |
Micron Technology, Inc. 2016-08-13 |
 QUANTX 87104547 5188464 Live/Registered |
Blue Sky Asset Management LLC 2016-07-14 |
 QUANTX 85090864 4218366 Live/Registered |
I & J Fisnar, Inc. 2010-07-22 |
 QUANTX 75928850 not registered Dead/Abandoned |
Advanced Cardiovascular Systems, Inc. 2000-02-26 |
 QUANTX 75914132 not registered Dead/Abandoned |
QuantX, Inc. 2000-01-12 |
 QUANTX 75372074 not registered Dead/Abandoned |
Ontogeny, Inc. 1997-10-14 |
 QUANTX 75372073 not registered Dead/Abandoned |
Ontogeny, Inc. 1997-10-14 |
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