Data / Medical devices / Italy / IMS GIOTTO S.p.A.
IMS GIOTTO S.p.A.: FDA-registered device maker in Sasso Marconi Bologna, Italy, 7 510(k) clearances
IMS GIOTTO S.p.A. is registered with the FDA (registration 9680027) in Sasso Marconi Bologna, Italy. It lists 2 device types. The FDA files 7 510(k) clearances under its listings, the newest dated July 14, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9680027
- FEI number
- 3002807317
- Address
- Via Sagittario, 5, Sasso Marconi Bologna, Italy, 40037
- Owner or operator
- IMS GIOTTO S.p.A. (10028474)
- Roles
- Manufacturer
- First device listed
- February 4, 2009
- Registered through
- 2026
- Brand names listed
- BIOPSY DIGIT, BIOPSY DIGIT S/SL, GIOTTO CLASS, GIOTTO IMAGE, GIOTTO IMAGE 3D-3DL, MAMMOBED, Smart Finder
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Full Field Digital, System, X-Ray, Mammographic | MUE | 2 | Manufacturer | accessdata.fda.gov |
| System, X-Ray, Mammographic | IZH | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 14, 2021 | K203509 | SMART FINDER | IZH | Substantially Equivalent | Ims Giotto S.P.A. | accessdata.fda.gov |
| June 18, 2020 | K200424 | Giotto Class (Models - 3000X-YY and 4000X-YY) | MUE | Substantially Equivalent | Ims Giotto S.P.A. | accessdata.fda.gov |
| August 10, 2012 | K113607 | BIOPSY DIGIT S BIOPSY SL | IZH | Substantially Equivalent | Giotto USA, LLC | accessdata.fda.gov |
| October 27, 2011 | K111434 | GIOTTO IMAGE 3D, GIOTTO IMAGE 3D-L | MUE | Substantially Equivalent | Giotto USA, LLC | accessdata.fda.gov |
| November 30, 2001 | K012953 | GIOTTO IMAGE | IZH | Substantially Equivalent | Medx, Inc. | accessdata.fda.gov |
| March 12, 1999 | K990192 | BIOPSY-DIGIT | IZH | Substantially Equivalent | Sitco, Inc. | accessdata.fda.gov |
| January 15, 1993 | K925212 | GIOTTO PATIENT BED | IZH | Substantially Equivalent | Gold Coast Imaging, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of System, X-Ray, Mammographic
- All makers of Full Field Digital, System, X-Ray, Mammographic
Updated July 14, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.