Device Classification Name |
system, tomography, computed, emission
|
510(k) Number |
K072468 |
Device Name |
MODIFICATION TO D-SPECT CARDIAC SCANNER SYSTEM |
Applicant |
SPECTRUM DYNAMICS LTD. |
20 HATA'AS ST. |
KFAR SABA,
IL
44425
|
|
Applicant Contact |
AHAVA STEIN |
Correspondent |
SPECTRUM DYNAMICS LTD. |
20 HATA'AS ST. |
KFAR SABA,
IL
44425
|
|
Correspondent Contact |
AHAVA STEIN |
Regulation Number | 892.1200
|
Classification Product Code |
|
Date Received | 09/04/2007 |
Decision Date | 10/01/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|