Cleared Traditional

Eclipse II with Smart Noise Cancellation

K213307 · Carestream Health, Inc. · Radiology
Jan 2022
Decision
102d
Days
Class 2
Risk

About This 510(k) Submission

K213307 is an FDA 510(k) clearance for the Eclipse II with Smart Noise Cancellation, a Solid State X-ray Imager (flat Panel/digital Imager) (Class II — Special Controls, product code MQB), submitted by Carestream Health, Inc. (Rochester, US). The FDA issued a Cleared decision on January 14, 2022, 102 days after receiving the submission on October 4, 2021. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number K213307 FDA.gov
FDA Decision Cleared SESE
Date Received October 04, 2021
Decision Date January 14, 2022
Days to Decision 102 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code MQB — Solid State X-ray Imager (flat Panel/digital Imager)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1680

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