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FDA 510(k)

PowerLook Tomo Detection V2 Software

K-Number: K182373 · 2018-12-06

ApplicantIcad, Inc.
Decision Date2018-12-06
Product CodeQDQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PowerLook Tomo Detection V2 Software is a medical device manufactured by Icad, Inc.. It received FDA 510(k) clearance on 2018-12-06 under approval number K182373. The device is classified under product code QDQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PowerLook Tomo Detection V2 Software?

PowerLook Tomo Detection V2 Software is a medical device that received FDA 510(k) clearance on 2018-12-06. It is manufactured by Icad, Inc.. The 510(k) number is K182373.

When was PowerLook Tomo Detection V2 Software approved by the FDA?

PowerLook Tomo Detection V2 Software received FDA 510(k) clearance on 2018-12-06, under approval number K182373.

What company makes PowerLook Tomo Detection V2 Software?

PowerLook Tomo Detection V2 Software is manufactured by Icad, Inc..

What is the FDA product code for PowerLook Tomo Detection V2 Software?

The FDA product code for PowerLook Tomo Detection V2 Software is QDQ.

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Related Devices (Code: QDQ)

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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.

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