# Fmi Medical Systems, Inc.

- Location (FDA's records): Solon, OH
- FDA decisions: 2 (2018–2020): 2 510(k) clearances
- Product codes: JAK (2)
- Predicates its devices cite: 3 (1 its own); citations of its devices by later devices: 1 (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
- Philips Medical Systems (Cleveland), Inc.: 1 (https://510kreport.com/company/philips-medical-systems-cleveland)
- Siemens Medical Solutions USA, Inc.: 1 (https://510kreport.com/company/siemens-medical-solutions-usa)

## Its most-cited devices
- K173076: CURA 16; ScintCare CT16 (2018), cited by 1

## Recent decisions
- K192590: CURA 778 (Mar 5, 2020)
- K173076: CURA 16; ScintCare CT16 (Oct 4, 2018)

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