PowerLook Density Assessment V4.0
K-Number: K211506 · 2021-07-12
ApplicantIcad, Inc.
Decision Date2021-07-12
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
PowerLook Density Assessment V4.0 is a medical device manufactured by Icad, Inc.. It received FDA 510(k) clearance on 2021-07-12 under approval number K211506. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the PowerLook Density Assessment V4.0?
PowerLook Density Assessment V4.0 is a medical device that received FDA 510(k) clearance on 2021-07-12. It is manufactured by Icad, Inc.. The 510(k) number is K211506.
When was PowerLook Density Assessment V4.0 approved by the FDA?
PowerLook Density Assessment V4.0 received FDA 510(k) clearance on 2021-07-12, under approval number K211506.
What company makes PowerLook Density Assessment V4.0?
PowerLook Density Assessment V4.0 is manufactured by Icad, Inc..
What is the FDA product code for PowerLook Density Assessment V4.0?
The FDA product code for PowerLook Density Assessment V4.0 is QIH.
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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.