Exo Iris (El2001)

System, Imaging, Pulsed Doppler, Ultrasonic

Exo Imaging Inc.

The following data is part of a premarket notification filed by Exo Imaging Inc. with the FDA for Exo Iris (el2001).

Pre-market Notification Details

Device IDK222198
510k NumberK222198
Device Name:Exo Iris (El2001)
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant Exo Imaging Inc. 4201 Burton Drive Santa Clara,  CA  95054
ContactAntoanela Gomard
CorrespondentAntoanela Gomard
Exo Imaging Inc. 4201 Burton Drive Santa Clara,  CA  95054
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-07-22
Decision Date2022-11-09

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