Device Classification Name |
System, X-Ray, Tomography, Computed
|
510(k) Number |
K003230 |
Device Name |
V SCORE WITH AUTO GATE MODEL TBD |
Applicant |
VITAL IMAGES, INC. |
3300 FERNBROOK LN. NORTH |
SUITE 200 |
PLYMOUTH,
MN
55447
|
|
Applicant Contact |
ROBERT C SAMEC |
Correspondent |
VITAL IMAGES, INC. |
3300 FERNBROOK LN. NORTH |
SUITE 200 |
PLYMOUTH,
MN
55447
|
|
Correspondent Contact |
ROBERT C SAMEC |
Regulation Number | 892.1750
|
Classification Product Code |
|
Date Received | 10/16/2000 |
Decision Date | 12/27/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|