Medical Device Manufacturer · US , Troy , NY

Brainlab Med. Computersysteme GmbH - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 1994

5

Total

5

Cleared

0

Denied

FDA 510(k) Regulatory Record - Brainlab Med. Computersysteme GmbH Radiology ✕

4 devices

1-4 of 4

Cleared May 12, 1997

BRAINLAB MICRO MULTI-LEAF COLLIMATOR

Radiology · 87d

Cleared Aug 05, 1996

BRAINLAB CT/X-RAY LOCALIZER

Radiology · 287d

Cleared Jun 05, 1995

BRAINLAB MASK SYSTEM

Radiology · 185d

Cleared Jul 22, 1994

BRAINLAB LINAC HARDWARE

Radiology · 304d