Device Classification Name |
Cabinet, X-Ray System
|
510(k) Number |
K082432 |
Device Name |
CORE VISION DIGITAL SPECIMEN RADIOGRAPHY (DSR) SYSTEM |
Applicant |
BIOPTICS, INC. |
15546 W. GELDING DR. |
SURPRISE,
AZ
85379
|
|
Applicant Contact |
PATRICIA WADE |
Correspondent |
BIOPTICS, INC. |
15546 W. GELDING DR. |
SURPRISE,
AZ
85379
|
|
Correspondent Contact |
PATRICIA WADE |
Regulation Number | 892.1680
|
Classification Product Code |
|
Date Received | 08/22/2008 |
Decision Date | 11/21/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|