DRX-Compass
K-Number: K201373 · 2020-06-26
ApplicantCarestream Health, Inc.
Decision Date2020-06-26
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
DRX-Compass is a medical device manufactured by Carestream Health, Inc.. It received FDA 510(k) clearance on 2020-06-26 under approval number K201373. 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-Compass?
DRX-Compass is a medical device that received FDA 510(k) clearance on 2020-06-26. It is manufactured by Carestream Health, Inc.. The 510(k) number is K201373.
When was DRX-Compass approved by the FDA?
DRX-Compass received FDA 510(k) clearance on 2020-06-26, under approval number K201373.
What company makes DRX-Compass?
DRX-Compass is manufactured by Carestream Health, Inc..
What is the FDA product code for DRX-Compass?
The FDA product code for DRX-Compass is KPR.
Other Devices by Carestream Health, Inc.
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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.