Eclipse II With Smart Noise Cancellation

Solid State X-ray Imager (flat Panel/digital Imager)

Carestream Health, Inc.

The following data is part of a premarket notification filed by Carestream Health, Inc. with the FDA for Eclipse Ii With Smart Noise Cancellation.

Pre-market Notification Details

Device IDK202441
510k NumberK202441
Device Name:Eclipse II With Smart Noise Cancellation
ClassificationSolid State X-ray Imager (flat Panel/digital Imager)
Applicant Carestream Health, Inc. 150 Verona Street Rochester,  NY  14608
ContactDuane Gutowski
CorrespondentGina Maiolo
Carestream Health, Inc. 150 Verona Street Rochester,  NY  14608
Product CodeMQB  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-26
Decision Date2021-04-02

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