Device Classification Name |
system, x-ray, extraoral source, digital
|
510(k) Number |
K061284 |
Device Name |
I-CAT 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 | 872.1800
|
Classification Product Code |
|
Date Received | 05/08/2006 |
Decision Date | 07/03/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|