The following data is part of a premarket notification filed by Metaltronica Spa with the FDA for Helianthus.
| Device ID | K202822 |
| 510k Number | K202822 |
| Device Name: | Helianthus |
| Classification | Full Field Digital, System, X-ray, Mammographic |
| Applicant | Metaltronica Spa 66 Via Delle Monachelle Pomezia Rm, IT Cap 00071 |
| Contact | Gloria Pesce Delfino |
| Correspondent | Rachel Paul Emergo Europe Consulting Prinsessegracht 20 The Hague, NL 2514ap |
| Product Code | MUE |
| CFR Regulation Number | 892.1715 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-24 |
| Decision Date | 2021-12-15 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() HELIANTHUS 90195200 not registered Live/Pending |
Yiwu Juyi Electronic Commerce Co., Ltd. 2020-09-20 |
![]() HELIANTHUS 85795200 4379417 Live/Registered |
NAM, Hye-Lyoung 2012-12-05 |
![]() HELIANTHUS 76157697 2551171 Dead/Expired |
Connery, Dan 2000-11-02 |
![]() HELIANTHUS 75609077 not registered Dead/Abandoned |
E'Conomica Global Image, Inc. 1998-12-21 |