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FDA 510(k)

INFANT WHOLE BODY SOFTWARE OPTION FOR QDR DENSITOMETERS

K-Number: K042480 · 2004-10-29

ApplicantHologic, Inc.
Decision Date2004-10-29
Product CodeKGI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

INFANT WHOLE BODY SOFTWARE OPTION FOR QDR DENSITOMETERS is the device name listed in this FDA 510(k) record. The listed applicant is Hologic, Inc.. It received FDA 510(k) clearance on 2004-10-29 under 510(k) number K042480. 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 INFANT WHOLE BODY SOFTWARE OPTION FOR QDR DENSITOMETERS?

INFANT WHOLE BODY SOFTWARE OPTION FOR QDR DENSITOMETERS is a medical device that received FDA 510(k) clearance on 2004-10-29. The listed applicant is Hologic, Inc.. The 510(k) number is K042480.

When did INFANT WHOLE BODY SOFTWARE OPTION FOR QDR DENSITOMETERS receive FDA 510(k) clearance?

INFANT WHOLE BODY SOFTWARE OPTION FOR QDR DENSITOMETERS received FDA 510(k) clearance on 2004-10-29, under 510(k) number K042480.

Who is the listed applicant for INFANT WHOLE BODY SOFTWARE OPTION FOR QDR DENSITOMETERS?

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 INFANT WHOLE BODY SOFTWARE OPTION FOR QDR DENSITOMETERS?

The FDA product code for INFANT WHOLE BODY SOFTWARE OPTION FOR QDR DENSITOMETERS is KGI.

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Other records listing Hologic, Inc. as applicant

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Related Devices (Code: KGI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254072BoneVueCurvebeam AI / Curvebeam, LLCK252718Lunar AstraGE Medical Systems Ultrasound & Primary Care Diagnostics, LLCK2510223D-SHAPER3D-Shaper Medical S.LK242295BunkerHill BMDBunkerHill HealthK243218TBS iNsight (V4)Medimaps Group SAK220402VirtuOstO.N. Diagnostics

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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