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FDA 510(k)

BI-RADS COMPANION

K-Number: K072258 · 2008-05-16

ApplicantAlmen Laboratories, Inc.
Decision Date2008-05-16
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BI-RADS COMPANION is the device name listed in this FDA 510(k) record. The listed applicant is Almen Laboratories, Inc.. It received FDA 510(k) clearance on 2008-05-16 under 510(k) number K072258. 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 BI-RADS COMPANION?

BI-RADS COMPANION is a medical device that received FDA 510(k) clearance on 2008-05-16. The listed applicant is Almen Laboratories, Inc.. The 510(k) number is K072258.

When did BI-RADS COMPANION receive FDA 510(k) clearance?

BI-RADS COMPANION received FDA 510(k) clearance on 2008-05-16, under 510(k) number K072258.

Who is the listed applicant for BI-RADS COMPANION?

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

What is the FDA product code for BI-RADS COMPANION?

The FDA product code for BI-RADS COMPANION is LLZ.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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