DRX-Evolution/Plus with Dual Energy
K-Number: K190330 · 2019-11-04
ApplicantCarestream Health, Inc.
Decision Date2019-11-04
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
DRX-Evolution/Plus with Dual Energy is a medical device manufactured by Carestream Health, Inc.. It received FDA 510(k) clearance on 2019-11-04 under approval number K190330. 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 DRX-Evolution/Plus with Dual Energy?
DRX-Evolution/Plus with Dual Energy is a medical device that received FDA 510(k) clearance on 2019-11-04. It is manufactured by Carestream Health, Inc.. The 510(k) number is K190330.
When was DRX-Evolution/Plus with Dual Energy approved by the FDA?
DRX-Evolution/Plus with Dual Energy received FDA 510(k) clearance on 2019-11-04, under approval number K190330.
What company makes DRX-Evolution/Plus with Dual Energy?
DRX-Evolution/Plus with Dual Energy is manufactured by Carestream Health, Inc..
What is the FDA product code for DRX-Evolution/Plus with Dual Energy?
The FDA product code for DRX-Evolution/Plus with Dual Energy 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.