FDA-Device2013-09-04Class II
BRAINLAB; FRAMELESS SRS QA TARGET POINTER Robotics is a device used to compensate rotational patient misalignment (roll and pitch) in a linear accelerator environment for stereotactic radiosurgery or radiotherapy procedures. The Frameless Radiosurgery Components are a device used for fixation, localization and repositioning of the patient's: head and neck; and head, neck, and shoulders, in a linear accelerator environment for stereotactic radiosurgery/radiotherapy procedures.
Brainlab AG
Hazard
The Frameless SRS QA Target Pointer - Pointer Cap with the engraved cross hairs may become loose even when only a moderate force is applied to the Pointer Cap.
Sold states
Worldwide Distribution - US Distribution only to AR., and the countries of Australia, Germany and Japan.
Affected count
6 units
Manufactured in
Kapellenstrasse 12, Feldkirchen, Germany
Products
BRAINLAB; FRAMELESS SRS QA TARGET POINTER Robotics is a device used to compensate rotational patient misalignment (roll and pitch) in a linear accelerator environment for stereotactic radiosurgery or radiotherapy procedures. The Frameless Radiosurgery Components are a device used for fixation, localization and repositioning of the patient's: head and neck; and head, neck, and shoulders, in a linear accelerator environment for stereotactic radiosurgery/radiotherapy procedures.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2083-2013Don't want to check this manually?
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