Device Classification Name |
system, x-ray, fluoroscopic, image-intensified
|
510(k) Number |
K142341 |
Device Name |
X-RAY TV SYSTEM SONIALVISION G4 |
Applicant |
SHIMADZU CORP. |
1 NISHINOKYO-KUWABARACHO |
NAKAYGO-KU |
KYOTO,
JP
604-8511
|
|
Applicant Contact |
TOSHIO KADOWAKI |
Correspondent |
SHIMADZU MEDICAL SYSTEMS |
20101 SOUTH VERMONT AVE. |
TORRANCE,
CA
90502 -1328
|
|
Correspondent Contact |
DON KARLE |
Regulation Number | 892.1650
|
Classification Product Code |
|
Date Received | 08/21/2014 |
Decision Date | 03/06/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|