Device Classification Name |
System, Documentation, Breast Lesion
|
510(k) Number |
K142926 |
Device Name |
iBreastExam |
Applicant |
UE LIFESCIENCES, INC. |
3711 MARKET STREET, SUITE 800 |
PHILADELPHIA,
PA
19104
|
|
Applicant Contact |
MIHIR SHAH |
Correspondent |
UE LIFESCIENCES, INC. |
3711 MARKET STREET, SUITE 800 |
PHILADELPHIA,
PA
19104
|
|
Correspondent Contact |
MIHIR SHAH |
Regulation Number | 884.2990
|
Classification Product Code |
|
Date Received | 10/08/2014 |
Decision Date | 04/23/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|