# Somatex Medical Technologies GmbH

- Location (FDA's records): Cambridge, MA
- FDA decisions: 7 (2008–2021): 7 510(k) clearances
- Product codes: NEU (6), KNW (1)
- 510(k) review time since 2016: median 90 days, against 89 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 10 (6 its own); citations of its devices by later devices: 10 (6 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Mri Devices Corp.: 2 (https://510kreport.com/company/mri-devices)
- Biopsybell S.R.L.: 1 (https://510kreport.com/company/biopsybell)
- Daum Corp.: 1 (https://510kreport.com/company/daum)

## Firms that cite its devices most
- Cianna Medical, Inc.: 2 (https://510kreport.com/company/cianna-medical)
- Superdimension, Ltd.: 1 (https://510kreport.com/company/superdimension)
- Endomagnetics Ltd.,: 1 (https://510kreport.com/company/endomagnetics)

## Its most-cited devices
- K073095: Tumark Professional, Model 271560; MR- Tumark Professional, Model 601560 (2008), cited by 4
- K093064: Tumark Professional, Model 271560, MR-Tumark Professional, Model 601560 (2010), cited by 4
- K111692: Tumark Flex for Mammotome,Tumark Flex for Atec (2011), cited by 2

## Recent decisions
- K201863: Tumark Vision, Tumark Professional, Tumark Q, Tumark Professional Q-Shape (Feb 18, 2021)
- K182082: Tumark for Eviva, Tumark for Brevera (Oct 31, 2018)
- K180443: Tumark Vision (Mar 22, 2018)
- K111692: Tumark Flex for Mammotome,Tumark Flex for Atec (Nov 8, 2011)
- K102771: Biopsy Handy, Mri Biopsy Handy (Jun 24, 2011)
- K093064: Tumark Professional, Model 271560, MR-Tumark Professional, Model 601560 (Feb 17, 2010)
- K073095: Tumark Professional, Model 271560; MR- Tumark Professional, Model 601560 (Mar 19, 2008)

Source page: https://510kreport.com/company/somatex-medical-technologies