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FDA 510(k) Applications for Medical Device Product Code "QNP"
FDA 510(k) Number
Applicant
Device Name
Decision Date
K211326
Chengdu Wision Medical Device Co., LTD.
EndoScreener
11/19/2021
K211951
Cosmo Artificial Intelligence - AI Ltd
GI Genius
07/23/2021
K231143
Cosmo Artificial Intelligence - AI Ltd
GI Genius System 100 and GI Genius System 200
05/19/2023
DEN200055
Cosmo Artificial Intelligence - AI, LTD
GI Genius
04/09/2021
K213686
Iterative Scopes Inc.
SKOUT Software
08/12/2022
K230658
Iterative Scopes Inc.
SKOUT« system
04/07/2023
K223473
Magentiq Eye LTD
ME-APDSÖ; MAGENTIQ-COLOÖ
07/25/2023
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