Brand Name | INTELEPACS |
Type of Device | PICTURE ARCHIVING AND COMMUNICATION SYSTEM |
Manufacturer (Section D) |
INTELERAD MEDICAL SYSTEMS |
800, boul. de maisonneuve e. |
12th floor |
montreal, quebec H2L 4 L8 |
CA H2L 4L8 |
|
Manufacturer (Section G) |
INTELERAD MEDICAL SYSTEMS |
800, boul. de maisonneuve e. |
12th floor |
montreal, quebec H2L 4 L8 |
CA
H2L 4L8
|
|
Manufacturer Contact |
luce
caron
|
800, boul. de maisonneuve e. |
12th floor |
montreal, quebec H2L 4-L8
|
CA
H2L 4L8
|
|
MDR Report Key | 9751805 |
MDR Text Key | 221577093 |
Report Number | 9615916-2020-00002 |
Device Sequence Number | 1 |
Product Code |
LLZ
|
UDI-Device Identifier | B228INTELEPACS0 |
UDI-Public | B228INTELEPACS0 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K150707 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,user faci |
Reporter Occupation |
Other Health Care Professional
|
Remedial Action |
Other |
Type of Report
| Initial |
Report Date |
02/20/2020 |
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 | INTELEPACS 4-9-1 AND UP |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
02/07/2020 |
Initial Date FDA Received | 02/25/2020 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 11/03/2016 |
Is the Device Single Use? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
|
|