PowerLook Density Assessment Software
K-Number: K180125 · 2018-04-05
ApplicantIcad, Inc.
Decision Date2018-04-05
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
PowerLook Density Assessment Software is a medical device manufactured by Icad, Inc.. It received FDA 510(k) clearance on 2018-04-05 under approval number K180125. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the PowerLook Density Assessment Software?
PowerLook Density Assessment Software is a medical device that received FDA 510(k) clearance on 2018-04-05. It is manufactured by Icad, Inc.. The 510(k) number is K180125.
When was PowerLook Density Assessment Software approved by the FDA?
PowerLook Density Assessment Software received FDA 510(k) clearance on 2018-04-05, under approval number K180125.
What company makes PowerLook Density Assessment Software?
PowerLook Density Assessment Software is manufactured by Icad, Inc..
What is the FDA product code for PowerLook Density Assessment Software?
The FDA product code for PowerLook Density Assessment Software is LLZ.
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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.