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 a medical device manufactured by Carestream Health, Inc.. It received FDA 510(k) clearance on 2018-06-21 under approval 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. It is manufactured by Carestream Health, Inc.. The 510(k) number is K180809.
When was Eclipse II approved by the FDA?
Eclipse II received FDA 510(k) clearance on 2018-06-21, under approval number K180809.
What company makes Eclipse II?
Eclipse II is manufactured by Carestream Health, Inc..
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.