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Microscope, Automated, Image Analysis, Operator Intervention

FDA product code NOT · Class 2 · Hematology

4
Registered devices
3
Adverse events
2
Recalls
13
510(k) clearances

Devices with this code

GenASIs™ System — APPLIED SPECTRAL IMAGING LTD.GenASIs™ System — APPLIED SPECTRAL IMAGING LTD.ASI IVD System — APPLIED SPECTRAL IMAGING LTD.ASI IVD System — APPLIED SPECTRAL IMAGING LTD.

Recent recalls

DateFirmReason
2018-12-10Leica Biosystems Imaging, Inc.The incorrect sensor was used in the assembly of the camera in the scanner instrument which can potentially generate whole slide images that impact analysis alg
2014-02-07Leica Biosystems Imaging, Inc.In an abundance of caution, Aperio (now known as Lecia Biosystems) is providing additional information to clarify that the use of Digital IHC Breast/ER/Dako Ima

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