Device Classification Name |
Full Field Digital, System, X-Ray, Mammographic
|
510(k) Number |
K173132 |
Device Name |
ASPIRE Cristalle |
Applicant |
Fujifilm Medical Systems U.S.A., Inc. |
419 West Avenue |
Stamford,
CT
06902
|
|
Applicant Contact |
Jyh-Shyan Lin |
Correspondent |
Fujifilm Medical Systems U.S.A., Inc. |
419 West Avenue |
Stamford,
CT
06902
|
|
Correspondent Contact |
Jyh-Shyan Lin |
Regulation Number | 892.1715
|
Classification Product Code |
|
Date Received | 09/29/2017 |
Decision Date | 10/27/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|