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FDA 510(k)

VERSAVUE ENTERPRISE SUITE

K-Number: K121517 · 2012-07-20

ApplicantIcad, Inc.
Decision Date2012-07-20
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VERSAVUE ENTERPRISE SUITE is the device name listed in this FDA 510(k) record. The listed applicant is Icad, Inc.. It received FDA 510(k) clearance on 2012-07-20 under 510(k) number K121517. 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 VERSAVUE ENTERPRISE SUITE?

VERSAVUE ENTERPRISE SUITE is a medical device that received FDA 510(k) clearance on 2012-07-20. The listed applicant is Icad, Inc.. The 510(k) number is K121517.

When did VERSAVUE ENTERPRISE SUITE receive FDA 510(k) clearance?

VERSAVUE ENTERPRISE SUITE received FDA 510(k) clearance on 2012-07-20, under 510(k) number K121517.

Who is the listed applicant for VERSAVUE ENTERPRISE SUITE?

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 VERSAVUE ENTERPRISE SUITE?

The FDA product code for VERSAVUE ENTERPRISE SUITE 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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