Device Classification Name |
Transducer, Ultrasonic, Diagnostic
|
510(k) Number |
K093462 |
Device Name |
SONIX ULTRASOUND SCANNER |
Applicant |
UltraSonix Medical Corporation |
130-4311 VIKING WAY |
RICHMOND, BRITISH COLUMBIA,
CA
V6V 2K9
|
|
Applicant Contact |
CHAS YU |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
MARK JOB |
Regulation Number | 892.1570
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 11/06/2009 |
Decision Date | 11/20/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|