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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 the device name listed in this FDA 510(k) record. The listed applicant is Icad, Inc.. It received FDA 510(k) clearance on 2018-12-06 under 510(k) 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. The listed applicant is Icad, Inc.. The 510(k) number is K182373.

When did PowerLook Tomo Detection V2 Software receive FDA 510(k) clearance?

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

Who is the listed applicant for PowerLook Tomo Detection V2 Software?

The FDA 510(k) record lists Icad, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Icad, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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