Carestream DRX-Evolution
K-Number: K163203 · 2016-12-13
ApplicantCarestream Health, Inc.
Decision Date2016-12-13
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Carestream DRX-Evolution is a medical device manufactured by Carestream Health, Inc.. It received FDA 510(k) clearance on 2016-12-13 under approval number K163203. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Carestream DRX-Evolution?
Carestream DRX-Evolution is a medical device that received FDA 510(k) clearance on 2016-12-13. It is manufactured by Carestream Health, Inc.. The 510(k) number is K163203.
When was Carestream DRX-Evolution approved by the FDA?
Carestream DRX-Evolution received FDA 510(k) clearance on 2016-12-13, under approval number K163203.
What company makes Carestream DRX-Evolution?
Carestream DRX-Evolution is manufactured by Carestream Health, Inc..
What is the FDA product code for Carestream DRX-Evolution?
The FDA product code for Carestream DRX-Evolution is KPR.
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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.