Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K160001 |
Device Name |
TraumaCad Mobile Release 2.0 |
Applicant |
Voyant Health Ltd |
35 Efal Street |
Petach-Tikva,
IL
4951132
|
|
Applicant Contact |
Yael Guttentag |
Correspondent |
Voyant Health Ltd |
35 Efal Street |
Petach-Tikva,
IL
4951132
|
|
Correspondent Contact |
Yael Guttentag |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 01/04/2016 |
Decision Date | 02/12/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|