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FDA 510(k)

MAMMOGRAPHY PRIOR ENHANCEMENT (MPE)

K-Number: K123530 · 2012-12-20

ApplicantHologic, Inc.
Decision Date2012-12-20
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MAMMOGRAPHY PRIOR ENHANCEMENT (MPE) is the device name listed in this FDA 510(k) record. The listed applicant is Hologic, Inc.. It received FDA 510(k) clearance on 2012-12-20 under 510(k) number K123530. 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 MAMMOGRAPHY PRIOR ENHANCEMENT (MPE)?

MAMMOGRAPHY PRIOR ENHANCEMENT (MPE) is a medical device that received FDA 510(k) clearance on 2012-12-20. The listed applicant is Hologic, Inc.. The 510(k) number is K123530.

When did MAMMOGRAPHY PRIOR ENHANCEMENT (MPE) receive FDA 510(k) clearance?

MAMMOGRAPHY PRIOR ENHANCEMENT (MPE) received FDA 510(k) clearance on 2012-12-20, under 510(k) number K123530.

Who is the listed applicant for MAMMOGRAPHY PRIOR ENHANCEMENT (MPE)?

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 MAMMOGRAPHY PRIOR ENHANCEMENT (MPE)?

The FDA product code for MAMMOGRAPHY PRIOR ENHANCEMENT (MPE) 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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