Giotto Class (Models - 3000X-YY and 4000X-YY)
FDA 510(k) K200424 · Ims Giotto S.P.A.
510(k) numberK200424
Submission
- Device name
- Giotto Class (Models - 3000X-YY and 4000X-YY)
- Applicant
- Ims Giotto S.P.A.
Sasso Marconi, IT - Received
- February 20, 2020
- Decision date
- June 18, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code MUE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254090 | I-View®MUE · Traditional | Hologic, Inc. | 09/02/2026SE |
| K253678 | MAMMOMAT B.brilliant (11372950)MUE · Traditional | Siemens Medical Solutions USA, Inc. | 06/18/2026SE |
| K254092 | Bellalun 2D (VDMS-1000S)MUE · Traditional | Vieworks Co., Ltd. | 05/28/2026SE |
| K260087 | Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena BrightMUE · Traditional | GE Medical Systems SCS | 03/24/2026SE |
| K243420 | HestiaMUE · Traditional | Genoray Co., Ltd. | 07/17/2025SE |
| K243849 | 2430TCA with Xmaru WMUE · Special | Rayence Co., Ltd. | 03/12/2025SE |
| K241113 | Vivix-MMUE · Traditional | Vieworks Co., Ltd. | 01/16/2025SE |
| K233539 | MAMMOMAT B.brilliantMUE · Traditional | Siemens Medical Solutions USA, Inc. | 03/27/2024SE |
| K220073 | RMF-2000MUE · Traditional | DRTECH Corporation | 01/26/2023SE |
| K211720 | Planmed Clarity 2D, Planmed Clarify SMUE · Traditional | Planmed OY | 07/18/2022SE |
More from Planmed OY
| 510(k) | Device | Decision |
|---|---|---|
| K203509 | Smart FinderIZH · Special | 07/14/2021SE |
Questions and answers
When was Giotto Class (Models - 3000X-YY and 4000X-YY) cleared by the FDA?
Giotto Class (Models - 3000X-YY and 4000X-YY) (K200424) received a 510(k) decision of Substantially Equivalent on June 18, 2020, 119 days after the submission was received.
What is the product code of K200424?
The FDA product code is MUE – Full Field Digital, System, X-Ray, Mammographic, a Class II (moderate risk) device regulated under 21 CFR 892.1715.