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FDA 510(k)

ICAD BREAST INTERVENTIONAL PLANNING SOFTWARE, MODEL D70024

K-Number: K090223 · 2009-03-31

ApplicantIcad, Inc.
Decision Date2009-03-31
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ICAD BREAST INTERVENTIONAL PLANNING SOFTWARE, MODEL D70024 is the device name listed in this FDA 510(k) record. The listed applicant is Icad, Inc.. It received FDA 510(k) clearance on 2009-03-31 under 510(k) number K090223. 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 ICAD BREAST INTERVENTIONAL PLANNING SOFTWARE, MODEL D70024?

ICAD BREAST INTERVENTIONAL PLANNING SOFTWARE, MODEL D70024 is a medical device that received FDA 510(k) clearance on 2009-03-31. The listed applicant is Icad, Inc.. The 510(k) number is K090223.

When did ICAD BREAST INTERVENTIONAL PLANNING SOFTWARE, MODEL D70024 receive FDA 510(k) clearance?

ICAD BREAST INTERVENTIONAL PLANNING SOFTWARE, MODEL D70024 received FDA 510(k) clearance on 2009-03-31, under 510(k) number K090223.

Who is the listed applicant for ICAD BREAST INTERVENTIONAL PLANNING SOFTWARE, MODEL D70024?

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 ICAD BREAST INTERVENTIONAL PLANNING SOFTWARE, MODEL D70024?

The FDA product code for ICAD BREAST INTERVENTIONAL PLANNING SOFTWARE, MODEL D70024 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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