# 3D Line Medical Systems S.R.L.

- Location (FDA's records): Milan, IT
- FDA decisions: 2 (2007–2008): 2 510(k) clearances
- Product codes: HAW (1), MUJ (1)
- Predicates its devices cite: 4 (0 its own); citations of its devices by later devices: 6 (0 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- 3D Line USA, Inc.: 3 (https://510kreport.com/company/3d-line-usa)
- Brainlab AG: 1 (https://510kreport.com/company/brainlab)

## Firms that cite its devices most
- Impac Medical Systems, Inc.: 2 (https://510kreport.com/company/impac-medical-systems)
- Computerized Medical Systems, Inc.: 2 (https://510kreport.com/company/computerized-medical-systems)
- Nuclemed S.A.: 1 (https://510kreport.com/company/nuclemed)
- Philips Medical Systems, Inc.: 1 (https://510kreport.com/company/philips-medical-systems)

## Its most-cited devices
- K080601: Ergo++ Version 1.7 (2008), cited by 6

## Recent decisions
- K080601: Ergo++ Version 1.7 (Jun 6, 2008)
- K061479: ARGOS (Apr 5, 2007)

Source page: https://510kreport.com/company/3d-line-medical-systems