Brand Name | CANON |
Type of Device | MAGNETIC RESONANCE IMAGING SYSTEM |
Manufacturer (Section D) |
CANON MEDICAL SYSEMS CORPORATION |
1385 shimioshigami |
otawara-shi,tochigi |
324-8 550, |
JA 324-8550, |
|
Manufacturer (Section G) |
CANON MEDICAL SYSEMS CORPORATION |
1385 shimioshigami |
otawara-shi,tochigi |
324-8 550, |
JA
324-8550,
|
|
Manufacturer Contact |
paul
biggins
|
2441 michelle drive |
tustin, CA 92870
|
7147307500
|
|
MDR Report Key | 14714560 |
MDR Text Key | 294936712 |
Report Number | 2020563-2022-00004 |
Device Sequence Number | 1 |
Product Code |
LNH
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
08/25/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 06/16/2022 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | MRT-3010 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 08/08/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 11/01/2013 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
Patient Sex | Female |
Patient Weight | 57 KG |
|
|