Eclipse II with Smart Noise Cancellation— 510(k) K202441

Substantially Equivalent

Carestream Health, Inc.

FDA 510(k) clearance K202441 for Eclipse II with Smart Noise Cancellation, Substantially Equivalent on 2021-04-02. Applicant: Carestream Health, Inc..

Clearance details

Applicant: Carestream Health, Inc.
Product code: Code MQB
Advisory panel: Radiology
Date received: 2020-08-26
Decision date: 2021-04-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

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