Device Classification Name |
system, imaging, pulsed doppler, ultrasonic
|
510(k) Number |
K063803 |
Device Name |
ACUSON ANTARES DIAGNOSTIC ULTRASOUND SYSTEM |
Applicant |
SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI |
1230 SHOREBIRD WAY |
P O BOX 7393 |
MOUNTAIN VIEW,
CA
94039 -7393
|
|
Applicant Contact |
MICHAELA MAHL |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
MARK JOB |
Regulation Number | 892.1550
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/22/2006 |
Decision Date | 01/05/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|