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FDA 510(k)

MAMMOSITE CAVITY EVALUATION DEVICE

K-Number: K081179 · 2008-05-09

ApplicantHologic, Inc.
Decision Date2008-05-09
Product CodeJAQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MAMMOSITE CAVITY EVALUATION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Hologic, Inc.. It received FDA 510(k) clearance on 2008-05-09 under 510(k) number K081179. The device is classified under product code JAQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAMMOSITE CAVITY EVALUATION DEVICE?

MAMMOSITE CAVITY EVALUATION DEVICE is a medical device that received FDA 510(k) clearance on 2008-05-09. The listed applicant is Hologic, Inc.. The 510(k) number is K081179.

When did MAMMOSITE CAVITY EVALUATION DEVICE receive FDA 510(k) clearance?

MAMMOSITE CAVITY EVALUATION DEVICE received FDA 510(k) clearance on 2008-05-09, under 510(k) number K081179.

Who is the listed applicant for MAMMOSITE CAVITY EVALUATION DEVICE?

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

What is the FDA product code for MAMMOSITE CAVITY EVALUATION DEVICE?

The FDA product code for MAMMOSITE CAVITY EVALUATION DEVICE is JAQ.

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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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