Brand Name | ILAB ULTRASOUND IMAGING SYSTEM |
Type of Device | SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC |
Manufacturer (Section D) |
BOSTON SCIENTIFIC - FREMONT (CE) |
47215 lakeview blvd |
north dock |
fremont CA 94538 |
|
Manufacturer (Section G) |
BOSTON SCIENTIFIC - FREMONT (CE) |
47215 lakeview blvd |
north dock |
fremont CA 94538 |
|
Manufacturer Contact |
sonali
arangil
|
one scimed place |
maple grove, MN 55311
|
7634941700
|
|
MDR Report Key | 7377370 |
MDR Text Key | 103727389 |
Report Number | 2134265-2018-02401 |
Device Sequence Number | 1 |
Product Code |
IYO
|
Combination Product (y/n) | N |
PMA/PMN Number | SIMILAR |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
03/07/2018 |
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 | H749ILAB100C270 |
Device Catalogue Number | ILAB100C27 |
Device Lot Number | 0000010343 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
03/07/2018
|
Initial Date FDA Received | 03/28/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 08/14/2015 |
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 |