FDA-Device2026-01-14Class II
The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position and movement.
Vision RT Ltd
Hazard
Vision RT is informing customers of an omission identified in the Instructions for Use for AlignRT InBore systems. Information identifying the lasers and their characteristics was omitted from the Instructions for Use for the subject system as required by 21 CFR 1040,10(h), via conformance with recognized consensus standard IEC 60825-1 Ed. 3 (FDA Laser Notice 56).
Sold states
U.S. and OUS
Affected count
56
Manufactured in
Dove House, Arcadia Avenue, London, United Kingdom
Products
The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position and movement.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0998-2026Don't want to check this manually?
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