FDA-Device2015-01-14Class II

AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment.

Vision Rt Inc
Hazard

Potential use error when the external Gate Controller is turned ON after the Vision RT software has been opened.

Sold states
Nationwide Distribution
Affected count
55
Manufactured in
8840 Stanford Blvd, N/A, Columbia, MD, United States
Products
AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0934-2015

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