Brand Name | MOSAIQ |
Type of Device | ACCELERATOR, LINEAR, MEDICAL |
Manufacturer (Section D) |
ELEKTA INC |
100 mathilda place |
5th floor |
sunnyvale CA 94086 |
|
MDR Report Key | 11064051 |
MDR Text Key | 223403626 |
Report Number | 2950347-2020-00044 |
Device Sequence Number | 1 |
Product Code |
IYE
|
UDI-Device Identifier | 00858164002091 |
UDI-Public | 00858164002091 |
Combination Product (y/n) | N |
PMA/PMN Number | K141572 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional,o |
Type of Report
| Initial,Followup |
Report Date |
09/03/2021 |
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? |
No
|
Device Operator |
Health Professional
|
Device Model Number | MOSAIQ |
Was Device Available for Evaluation? |
Yes
|
Initial Date Manufacturer Received |
12/02/2020 |
Initial Date FDA Received | 12/23/2020 |
Supplement Dates Manufacturer Received | 12/02/2020
|
Supplement Dates FDA Received | 09/03/2021
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|