Device Classification Name |
System, Imaging, Pulsed Echo, Ultrasonic
|
510(k) Number |
K130243 |
Device Name |
ILAB ULTRASOUND IMAGING SYSTEM |
Applicant |
BOSTON SCIENTIFIC CORP. |
47215 LAKEVIEW BLVD |
FREMONT,
CA
94538 -6515
|
|
Applicant Contact |
LORI R SMITH |
Correspondent |
BOSTON SCIENTIFIC CORP. |
47215 LAKEVIEW BLVD |
FREMONT,
CA
94538 -6515
|
|
Correspondent Contact |
LORI R SMITH |
Regulation Number | 892.1560
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/31/2013 |
Decision Date | 03/01/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|