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FDA 510(k)

HOLOGIC VISCERAL FAT SOFTWARE

K-Number: K113356 · 2012-03-06

ApplicantHologic, Inc.
Decision Date2012-03-06
Product CodeKGI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HOLOGIC VISCERAL FAT SOFTWARE is the device name listed in this FDA 510(k) record. The listed applicant is Hologic, Inc.. It received FDA 510(k) clearance on 2012-03-06 under 510(k) number K113356. The device is classified under product code KGI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HOLOGIC VISCERAL FAT SOFTWARE?

HOLOGIC VISCERAL FAT SOFTWARE is a medical device that received FDA 510(k) clearance on 2012-03-06. The listed applicant is Hologic, Inc.. The 510(k) number is K113356.

When did HOLOGIC VISCERAL FAT SOFTWARE receive FDA 510(k) clearance?

HOLOGIC VISCERAL FAT SOFTWARE received FDA 510(k) clearance on 2012-03-06, under 510(k) number K113356.

Who is the listed applicant for HOLOGIC VISCERAL FAT SOFTWARE?

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 HOLOGIC VISCERAL FAT SOFTWARE?

The FDA product code for HOLOGIC VISCERAL FAT SOFTWARE is KGI.

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Related Devices (Code: KGI)

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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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