Device Classification Name |
coil, magnetic resonance, specialty
|
510(k) Number |
K073236 |
Device Name |
NEOCOIL 3.0T 32-CHANNEL TORSO ARRAY COIL FOR GE |
Applicant |
NEOCOIL |
N27 W23910A PAUL RD. |
PEWAUKEE,
WI
53072
|
|
Applicant Contact |
BRIAN BROWN |
Correspondent |
INTERTEK TESTING SERVICES |
2307 EAST AURORA ROAD |
UNIT B7 |
TWINSBURG,
OH
44087
|
|
Correspondent Contact |
DANIEL W LEHTONEN |
Regulation Number | 892.1000
|
Classification Product Code |
|
Date Received | 11/16/2007 |
Decision Date | 11/30/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|