Device Classification Name |
system, automated scanning microscope and image analysis for fluorescence in situ hybridization (fish) assays
|
510(k) Number |
K122554 |
Device Name |
GENASIS SCANVIEW SYSTEM |
Applicant |
APPLIED SPECTRAL IMAGING, LTD. |
A-109 NETO- GOLF |
CAESAREA,
IL
30889
|
|
Applicant Contact |
ILAN SHARON |
Correspondent |
APPLIED SPECTRAL IMAGING, LTD. |
A-109 NETO- GOLF |
CAESAREA,
IL
30889
|
|
Correspondent Contact |
ILAN SHARON |
Regulation Number | 866.4700
|
Classification Product Code |
|
Date Received | 08/21/2012 |
Decision Date | 02/07/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Immunology
|
510k Review Panel |
Pathology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Clinical Trials |
NCT01620853
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|