Giotto USA, LLC
United StatesFDA applicant, unverified
- Devices
- 3
What Giotto USA, LLC makes
Giotto USA, LLC manufactures digital biopsy devices, including the DIGIT-AM and DIGIT S BIOPSY SL systems, as well as 3D imaging tools like the GIOTTO IMAGE 3D and GIOTTO IMAGE 3D-L for medical diagnostics.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) clearance process. The company is based in the United States.
Catalogue
Biopsy Digit-Am Ref K062039
Regimes: 510(k) Registry: 510(k)Giotto Image 3D, Giotto Image 3D-L Ref K111434
Regimes: 510(k) Registry: 510(k)Biopsy Digit S Biopsy Sl Ref K113607
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Giotto USA, LLC have in the registry?
The registry currently lists 3 devices for Giotto USA, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Giotto USA, LLC's devices?
Among its 3 most recently registered devices, Giotto USA, LLC has devices listed in FDA 510(k) (3 devices).
What risk classes do Giotto USA, LLC's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Giotto USA, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Giotto USA, LLC in the registry?
The most recently registered devices listed for Giotto USA, LLC include BIOPSY DIGIT-AM, GIOTTO IMAGE 3D, GIOTTO IMAGE 3D-L and BIOPSY DIGIT S BIOPSY SL.