qlarityimaging.comQuantX Breast MRI Biopsy Guidance Plugin
Qlarity Imaging
QLARITY IMAGING
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3015529351 | 3015529351 | QLARITY IMAGING | 1 | N | 2020-04-25 | 330 N Wabash Suite 3500 Chicago IL US 60611 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| B80711 | QuantX - 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. | 312-847-1627 | mjohnston@qlarityimaging.com |
| B80711 | QuantX - 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. | 312-847-1622 | mharrison@qlarityimaging.com |
| B80721 | QuantX - 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. | 312-847-1627 | mjohnston@qlarityimaging.com |
| B80721 | QuantX - 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. | 312-847-1622 | mharrison@qlarityimaging.com |
| B80731 | QuantX - QuantX is a software program that is used to view and analyze patient breast images. | 312-847-1627 | mjohnston@qlarityimaging.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 231515 | 1285306492 | K191959 | QuantX Breast MRI Biopsy Guidance Plugin | LLZ | 2019-11-08 |
| 231515 | 1218993668 | K170195 | QuantX | LLZ | 2017-05-17 |
| 231515 | 1222067503 | DEN170022 | QuantX | POK | 2017-07-19 |
Product Codes Associated With Registrations#
PMN#
GUDID#
QuantX - 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.
2020-02-27
QuantX - 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.
2020-02-19
QuantX - QuantX is a software program that is used to view and analyze patient breast images.
2020-02-19