Insight Agile DRF
K-Number: K210469 · 2021-07-27
ApplicantImaging Engineering, LLC
Decision Date2021-07-27
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Insight Agile DRF is a medical device manufactured by Imaging Engineering, LLC. It received FDA 510(k) clearance on 2021-07-27 under approval number K210469. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Insight Agile DRF?
Insight Agile DRF is a medical device that received FDA 510(k) clearance on 2021-07-27. It is manufactured by Imaging Engineering, LLC. The 510(k) number is K210469.
When was Insight Agile DRF approved by the FDA?
Insight Agile DRF received FDA 510(k) clearance on 2021-07-27, under approval number K210469.
What company makes Insight Agile DRF?
Insight Agile DRF is manufactured by Imaging Engineering, LLC.
What is the FDA product code for Insight Agile DRF?
The FDA product code for Insight Agile DRF is JAA.
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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.