Device Classification Name |
interventional fluoroscopic x-ray system
|
510(k) Number |
K142740 |
Device Name |
Ziehm Vision RFD 3D |
Applicant |
ZIEHM IMAGING GMBH |
DONAUSTRASSE 31 |
NUREMBERG,
DE
D-90451
|
|
Applicant Contact |
STEFAN FIEDLER |
Correspondent |
ZIEHM IMAGING GMBH |
6280 HAZELTINE NATIONAL DR. |
ORLANDO,
FL
32822
|
|
Correspondent Contact |
RICHARD L WESTRICH |
Regulation Number | 892.1650
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 09/24/2014 |
Decision Date | 04/06/2015 |
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
|
|
|