Eclipse II with Smart Noise Cancellation— 510(k) K213307

Name: FDA 510(k) clearance K213307
Creator: U.S. Food and Drug Administration
Published: 2022-01-14

Substantially Equivalent

Carestream Health, Inc.

FDA 510(k) clearance K213307 for Eclipse II with Smart Noise Cancellation, Substantially Equivalent on 2022-01-14. Applicant: Carestream Health, Inc.. Device class: 2.

Clearance details

Applicant: Carestream Health, Inc.
Product code: Code MQB
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2021-10-04
Decision date: 2022-01-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.