# Brainlab Med. Computersysteme GmbH

- Location (FDA's records): 85586 Poing/Munchen, DE
- FDA decisions: 5 (1994–1997): 5 510(k) clearances
- Product codes: IYE (4), HAW (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 9 (0 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Brainlab AG: 3 (https://510kreport.com/company/brainlab)
- Direx Systems Corp.: 2 (https://510kreport.com/company/direx-systems)
- Aktina Medical Physics Corp.: 2 (https://510kreport.com/company/aktina-medical-physics)
- Varian Medical Systems, Inc.: 1 (https://510kreport.com/company/varian-medical-systems)
- Radionics, Inc.: 1 (https://510kreport.com/company/radionics)

## Its most-cited devices
- K970586: Brainlab Micro Multi-Leaf Collimator (1997), cited by 4
- K954861: Brainlab CT/X-Ray Localizer (1996), cited by 2
- K945903: Brainlab Mask System (1995), cited by 2
- K934657: Brainlab Linac Hardware (1994), cited by 1

## Recent decisions
- K970586: Brainlab Micro Multi-Leaf Collimator (May 12, 1997)
- K954861: Brainlab CT/X-Ray Localizer (Aug 5, 1996)
- K952390: Brainlab Sterotatic Headring (Feb 2, 1996)
- K945903: Brainlab Mask System (Jun 5, 1995)
- K934657: Brainlab Linac Hardware (Jul 22, 1994)

Source page: https://510kreport.com/company/brainlab-med-computersysteme