Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K063505 |
Device Name |
VISUALASE ENVISION SOFTWARE SYSTEM |
Applicant |
BIOTEX, INC. |
8058 EL RIO ST. |
HOUSTON,
TX
77054 -4185
|
|
Applicant Contact |
MATHEW FOX |
Correspondent |
BIOTEX, INC. |
8058 EL RIO ST. |
HOUSTON,
TX
77054 -4185
|
|
Correspondent Contact |
MATHEW FOX |
Regulation Number | 892.2050
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/20/2006 |
Decision Date | 12/12/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|