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FDA 510(k)

SECOND LOOK VIEWER

K-Number: K042697 · 2004-11-19

ApplicantIcad, Inc.
Decision Date2004-11-19
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SECOND LOOK VIEWER is the device name listed in this FDA 510(k) record. The listed applicant is Icad, Inc.. It received FDA 510(k) clearance on 2004-11-19 under 510(k) number K042697. 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 SECOND LOOK VIEWER?

SECOND LOOK VIEWER is a medical device that received FDA 510(k) clearance on 2004-11-19. The listed applicant is Icad, Inc.. The 510(k) number is K042697.

When did SECOND LOOK VIEWER receive FDA 510(k) clearance?

SECOND LOOK VIEWER received FDA 510(k) clearance on 2004-11-19, under 510(k) number K042697.

Who is the listed applicant for SECOND LOOK VIEWER?

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 SECOND LOOK VIEWER?

The FDA product code for SECOND LOOK VIEWER 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.

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