# Giotto USA, LLC

- Location (FDA's records): Indianpolis, IN
- FDA decisions: 3 (2006–2012): 3 510(k) clearances
- Product codes: IZH (2), MUE (1)
- Predicates its devices cite: 4 (1 its own); citations of its devices by later devices: 2 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- GE Healthcare: 1 (https://510kreport.com/company/ge-healthcare)
- Medx, Inc.: 1 (https://510kreport.com/company/medx)
- Sitco, Inc.: 1 (https://510kreport.com/company/sitco)

## Firms that cite its devices most
- Xpress Bcd, LLC: 1 (https://510kreport.com/company/xpress-bcd)

## Its most-cited devices
- K113607: Biopsy Digit S Biopsy SL (2012), cited by 1
- K062039: Biopsy Digit-AM (2006), cited by 1

## Recent decisions
- K113607: Biopsy Digit S Biopsy SL (Aug 10, 2012)
- K111434: Giotto Image 3D, Giotto Image 3D-L (Oct 27, 2011)
- K062039: Biopsy Digit-AM (Sep 11, 2006)

Source page: https://510kreport.com/company/giotto-usa