Device Classification Name |
Transducer, Ultrasonic, Diagnostic
|
510(k) Number |
K072918 |
Device Name |
MODEL SSA-680A XARIO XG DIAGNOSTIC ULTRASOUND SYSTEM, VERSION 1.00 |
Applicant |
TOSHIBA MEDICAL SYSTEMS CORPORATION |
2441 MICHELLE DRIVE |
TUSTIN,
CA
92780
|
|
Applicant Contact |
PAUL BIGGINS |
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 | 10/15/2007 |
Decision Date | 10/29/2007 |
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
|
|
|