Device Classification Name |
System, Imaging, Pulsed Echo, Ultrasonic
|
510(k) Number |
K092619 |
Device Name |
ETRAX NEEDLE SYSTEM, ETRAX VARIABLE ANGLE NEEDLE GUIDANCE SYSTEM, VIRTUTRAX UNIVERSAL TRACKER |
Applicant |
CIVCO |
102 FIRST ST. SOUTH |
KALONA,
IA
52247
|
|
Applicant Contact |
JAMES LEONG |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
MARK JOB |
Regulation Number | 892.1560
|
Classification Product Code |
|
Date Received | 08/26/2009 |
Decision Date | 11/13/2009 |
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
|
|
|