DRX - Compass
K-Number: K223842 · 2023-01-20
ApplicantCarestream Health, Inc.
Decision Date2023-01-20
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 2023-01-20 under approval number K223842. 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 2023-01-20. It is manufactured by Carestream Health, Inc.. The 510(k) number is K223842.
When was DRX - Compass approved by the FDA?
DRX - Compass received FDA 510(k) clearance on 2023-01-20, under approval number K223842.
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.