| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
| |
| Device | QVCAD SYSTEM |
|---|
| Generic Name | Analyzer, medical image |
|---|
| Regulation Number | 892.2070 |
|---|
| Applicant | QView Medical, Inc.
4546 EL CAMINO REAL
SUITE 215
LOS ALTOS, CA 94022 |
|---|
| PMA Number | P150043 |
|---|
| Date Received | 11/23/2015 |
|---|
| Decision Date | 11/09/2016 |
|---|
|
Reclassified Date
|
02/21/2020 |
|---|
| Product Code |
MYN |
| Docket Number | 16M-3914 |
|---|
| Notice Date | 11/16/2016 |
|---|
| Advisory Committee |
Radiology |
|---|
| Expedited Review Granted? | No |
|---|
| Combination Product | No |
|---|
Approval Order Statement
Approval for the QVCAD System. The QVCAD System is indicated for use as an aid to the reader during screening procedures in searching images of female breasts produced by the somo.v Automated Breast Ultrasound System (screening mammography BI- RADS® Assessment Category 1 or 2, and BI-RADS Composition/Density c or d) to detect mammography-occult lesions in regions not known to have suspicious findings. The indicators produced by the QVCAD System are not intended to be used for diagnostic characterization of suspicious findings. |
| Approval Order | Approval Order |
|---|
| Summary | Summary of Safety and Effectiveness |
|---|
| Labeling | Labeling
|
|---|
| Supplements: |
S001 |
|
|
