The following data is part of a premarket notification filed by Ims Giotto S.p.a. with the FDA for Giotto Class (models - 3000x-yy And 4000x-yy).
| Device ID | K200424 |
| 510k Number | K200424 |
| Device Name: | Giotto Class (Models - 3000X-YY And 4000X-YY) |
| Classification | Full Field Digital, System, X-ray, Mammographic |
| Applicant | IMS GIOTTO S.p.A. Via Sagittario 5 Sasso Marconi, IT 40037 |
| Contact | Antonella Rossi |
| Correspondent | Marisa Testa THEMA SRL Via Saragat, 5 Imola, IT 40026 |
| Product Code | MUE |
| CFR Regulation Number | 892.1715 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-20 |
| Decision Date | 2020-06-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18056977360059 | K200424 | 000 |
| 18056977360042 | K200424 | 000 |
| 18056977360035 | K200424 | 000 |
| 08056977360021 | K200424 | 000 |
| 18056977360011 | K200424 | 000 |
| 18056977360004 | K200424 | 000 |