Q-Rad System
K-Number: K193574 · 2020-01-22
ApplicantCarestream Health, Inc.
Decision Date2020-01-22
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Q-Rad System is a medical device manufactured by Carestream Health, Inc.. It received FDA 510(k) clearance on 2020-01-22 under approval number K193574. 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 Q-Rad System?
Q-Rad System is a medical device that received FDA 510(k) clearance on 2020-01-22. It is manufactured by Carestream Health, Inc.. The 510(k) number is K193574.
When was Q-Rad System approved by the FDA?
Q-Rad System received FDA 510(k) clearance on 2020-01-22, under approval number K193574.
What company makes Q-Rad System?
Q-Rad System is manufactured by Carestream Health, Inc..
What is the FDA product code for Q-Rad System?
The FDA product code for Q-Rad System 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.