# Alltech Medical Systems America, Inc.

- Location (FDA's records): Solon, OH
- FDA decisions: 4 (2008–2017): 4 510(k) clearances
- Product codes: LNH (4)
- Predicates its devices cite: 3 (3 its own); citations of its devices by later devices: 3 (3 its own)
- Recalls linked to its devices: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Its most-cited devices
- K082100: Alltech Echostar 1.5 T MR System (2008), cited by 1
- K113511: Echostar Spica 1.5T MR System (2012), cited by 1
- K141945: Echostar Comfort 1.5T Mri (2015), cited by 1

## Recent decisions
- K163192: Comfort EC710 (Apr 10, 2017)
- K141945: Echostar Comfort 1.5T Mri (Feb 3, 2015)
- K113511: Echostar Spica 1.5T MR System (May 2, 2012)
- K082100: Alltech Echostar 1.5 T MR System (Aug 6, 2008)

Source page: https://510kreport.com/company/alltech-medical-systems-america