# Syntheticmr AB

- Location (FDA's records): Linkoping, SE
- FDA decisions: 6 (2017–2021): 6 510(k) clearances
- Product codes: LNH (6)
- 510(k) review time since 2016: median 63 days, against 110 for FDA's reviews in the same codes and years (4 of 6 faster)
- Predicates its devices cite: 1 (0 its own); citations of its devices by later devices: 4 (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
- GE Medical Systems: 1 (https://510kreport.com/company/ge-medical-systems)

## Firms that cite its devices most
- Terran Biosciences, Inc.: 1 (https://510kreport.com/company/terran-biosciences)
- Syntheticmr AB (Publ.): 1 (https://510kreport.com/company/syntheticmr-ab-publ)
- Spintech, Inc.: 1 (https://510kreport.com/company/spintech)
- Subtle Medical, Inc.: 1 (https://510kreport.com/company/subtle-medical)

## Its most-cited devices
- K181093: SyMRI (2018), cited by 1
- K203372: SyMRI (2021), cited by 1
- K191036: SyMRI (2019), cited by 1
- K201616: SyMRI (2020), cited by 1

## Recent decisions
- K203372: SyMRI (Nov 3, 2021)
- K201616: SyMRI (Jul 28, 2020)
- K191036: SyMRI (Jun 13, 2019)
- K181093: SyMRI (Jun 12, 2018)
- K173558: SyMRI (Jan 26, 2018)
- K162943: SyMRI (Aug 29, 2017)

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