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FDA 510(k)

Eclipse II

K-Number: K180809 · 2018-06-21

ApplicantCarestream Health, Inc.
Decision Date2018-06-21
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Eclipse II is the device name listed in this FDA 510(k) record. The listed applicant is Carestream Health, Inc.. It received FDA 510(k) clearance on 2018-06-21 under 510(k) number K180809. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Eclipse II?

Eclipse II is a medical device that received FDA 510(k) clearance on 2018-06-21. The listed applicant is Carestream Health, Inc.. The 510(k) number is K180809.

When did Eclipse II receive FDA 510(k) clearance?

Eclipse II received FDA 510(k) clearance on 2018-06-21, under 510(k) number K180809.

Who is the listed applicant for Eclipse II?

The FDA 510(k) record lists Carestream Health, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Eclipse II?

The FDA product code for Eclipse II is MQB.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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