Carl Zeiss Surgical GmbH
Country not established
- Devices
- 4
What Carl Zeiss Surgical GmbH makes
Carl Zeiss Surgical GmbH manufactures intraoperative radiotherapy systems, including the INTRABEAM System with balloon applicators and needle applicators for targeted radiation delivery during surgery. The portfolio also includes the ZEISS INFRARED 800 imaging system with optional Flow 800 functionality for real-time visualization during procedures.
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearance records. The company operates with a US presence, though its headquarters are based in Germany.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Intrabeam System Ref K051055
Regimes: 510(k) Registry: 510(k)Zeiss Infrared 800 With Flow 800 Option Ref K100468
Regimes: 510(k) Registry: 510(k)Intrabeam Needle Applicator Ref K110590
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Carl Zeiss Surgical GmbH have in the registry?
The registry currently lists 4 devices for Carl Zeiss Surgical GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list Carl Zeiss Surgical GmbH's devices?
Among its 4 most recently registered devices, Carl Zeiss Surgical GmbH has devices listed in FDA 510(k) (4 devices).
What risk classes do Carl Zeiss Surgical GmbH's devices fall under?
Among its 4 most recently registered devices, the classes recorded for Carl Zeiss Surgical GmbH's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Carl Zeiss Surgical GmbH in the registry?
The most recently registered devices listed for Carl Zeiss Surgical GmbH include INTRABEAM SYSTEM WITH BALLOON APPLICATOR AND CBG SETS, INTRABEAM SYSTEM, ZEISS INFRARED 800 WITH FLOW 800 OPTION and INTRABEAM NEEDLE APPLICATOR.