FDA-Device2018-11-28Class II
DeltaVision OMX SR Imaging System Model Number: 29115476 The DeltaVision OMX SR Imaging System is a piece of laboratory equipment for super resolution imaging offluorescently-la beling biological samples. Techniques such as 3D Structured Illumination, Total Internal Reflection Fluorescence and localization microscopy may be used to examine a variety of samples over long periods of time.
GE Healthcare Biosciences
Hazard
Non-conformance with the DeltaVision OMX SR, the interlocks are not wired in a redundant fashion to make the interlock system single-fault tolerant.
Sold states
Worldwide - US Nationwide Distribution
Affected count
39
Manufactured in
14 Walkup Dr, N/A, Westborough, MA, United States
Products
DeltaVision OMX SR Imaging System Model Number: 29115476 The DeltaVision OMX SR Imaging System is a piece of laboratory equipment for super resolution imaging offluorescently-la beling biological samples. Techniques such as 3D Structured Illumination, Total Internal Reflection Fluorescence and localization microscopy may be used to examine a variety of samples over long periods of time.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0388-2019Don't want to check this manually?
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