Brand Name | SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM |
Type of Device | FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM |
Manufacturer (Section D) |
HOLOGIC, INC |
36 & 37 apple ridge road |
danbury, ct |
|
Manufacturer Contact |
kristin
fornieri
|
36 & 37 apple ridge road |
danbury, ct
|
7318491
|
|
MDR Report Key | 10007595 |
MDR Text Key | 189453837 |
Report Number | 1220984-2020-00050 |
Device Sequence Number | 1 |
Product Code |
MUE
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P010025 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
user facility |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
05/03/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | SDM-00001-2D |
Device Catalogue Number | SDM-00001-2D |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
05/03/2018
|
Initial Date FDA Received | 04/28/2020 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 03/01/2012 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
|
|