Device Classification Name |
Full Field Digital, System, X-Ray, Mammographic
|
510(k) Number |
K202822 |
Device Name |
Helianthus |
Applicant |
Metaltronica Spa |
66 via delle Monachelle |
Pomezia RM,
IT
CAP 00071
|
|
Applicant Contact |
Gloria Pesce Delfino |
Correspondent |
Emergo Europe Consulting |
Prinsessegracht 20 |
The Hague,
NL
2514AP
|
|
Correspondent Contact |
Rachel Paul |
Regulation Number | 892.1715
|
Classification Product Code |
|
Date Received | 09/24/2020 |
Decision Date | 12/15/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|