Device Classification Name |
System, X-Ray, Tomography, Computed
|
510(k) Number |
K051980 |
FOIA Releasable 510(k) |
K051980
|
Device Name |
DVT SCANNER |
Applicant |
IMAGING SCIENCES INTL., INC. |
1910 NORTH PENN RD. |
HATFIELD,
PA
19440
|
|
Applicant Contact |
DAVID W COWAN |
Correspondent |
IMAGING SCIENCES INTL., INC. |
1910 NORTH PENN RD. |
HATFIELD,
PA
19440
|
|
Correspondent Contact |
DAVID W COWAN |
Regulation Number | 892.1750
|
Classification Product Code |
|
Date Received | 07/21/2005 |
Decision Date | 08/19/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|