Device Classification Name |
System, X-Ray, Fluoroscopic, Image-Intensified
|
510(k) Number |
K110785 |
Device Name |
KALARE DIAGNOSTIC X-RAY TABLE SYSTEM |
Applicant |
TOSHIBA MEDICAL SYSTEMS COPORATION, JAPAN |
2441 MICHELLE DR |
TUSTIN,
CA
92780
|
|
Applicant Contact |
PAUL BIGGINS |
Correspondent |
TOSHIBA MEDICAL SYSTEMS COPORATION, JAPAN |
2441 MICHELLE DR |
TUSTIN,
CA
92780
|
|
Correspondent Contact |
PAUL BIGGINS |
Regulation Number | 892.1650
|
Classification Product Code |
|
Date Received | 03/21/2011 |
Decision Date | 05/27/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|