# Combinostics OY

- Location (FDA's records): Tampere, FI
- FDA decisions: 3 (2018–2024): 3 510(k) clearances
- Product codes: LLZ (2), KPS (1)
- 510(k) review time since 2016: median 202 days, against 105 for FDA's reviews in the same codes and years (0 of 3 faster)
- Predicates its devices cite: 4 (0 its own); citations of its devices by later devices: 2 (0 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
- Cortechs Labs, Inc.: 1 (https://510kreport.com/company/cortechs-labs)
- Icometrix NV: 1 (https://510kreport.com/company/icometrix)
- GE Healthcare: 1 (https://510kreport.com/company/ge-healthcare)
- GE Medical Systems: 1 (https://510kreport.com/company/ge-medical-systems)

## Firms that cite its devices most
- Vuno, Inc.: 1 (https://510kreport.com/company/vuno)
- Cortechs Labs, Inc.: 1 (https://510kreport.com/company/cortechs-labs)

## Its most-cited devices
- K171328: cNeuro cMRI (2018), cited by 1
- K231576: cNeuro cPET (2023), cited by 1

## Recent decisions
- K233908: cNeuro cDAT (Jul 1, 2024)
- K231576: cNeuro cPET (Sep 14, 2023)
- K171328: cNeuro cMRI (Jan 8, 2018)

Source page: https://510kreport.com/company/combinostics