Device Classification Name |
System, Tomography, Computed, Emission
|
510(k) Number |
K122241 |
Device Name |
IMAGEN3D |
Applicant |
CARDIOVASCULAR IMAGING TECHNOLOGIES |
9755 RIDGE DRIVE |
LENEXA,
KS
66219
|
|
Applicant Contact |
MELANIE HASEK |
Correspondent |
CARDIOVASCULAR IMAGING TECHNOLOGIES |
9755 RIDGE DRIVE |
LENEXA,
KS
66219
|
|
Correspondent Contact |
MELANIE HASEK |
Regulation Number | 892.1200
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/27/2012 |
Decision Date | 10/24/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|