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FDA 510(k)

HOLOGIC QDR-3000 X-RAY BONE DENSITOMETER

K-Number: K943505 · 1995-01-20

ApplicantHologic, Inc.
Decision Date1995-01-20
Product CodeKGI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HOLOGIC QDR-3000 X-RAY BONE DENSITOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Hologic, Inc.. It received FDA 510(k) clearance on 1995-01-20 under 510(k) number K943505. 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 QDR-3000 X-RAY BONE DENSITOMETER?

HOLOGIC QDR-3000 X-RAY BONE DENSITOMETER is a medical device that received FDA 510(k) clearance on 1995-01-20. The listed applicant is Hologic, Inc.. The 510(k) number is K943505.

When did HOLOGIC QDR-3000 X-RAY BONE DENSITOMETER receive FDA 510(k) clearance?

HOLOGIC QDR-3000 X-RAY BONE DENSITOMETER received FDA 510(k) clearance on 1995-01-20, under 510(k) number K943505.

Who is the listed applicant for HOLOGIC QDR-3000 X-RAY BONE DENSITOMETER?

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 QDR-3000 X-RAY BONE DENSITOMETER?

The FDA product code for HOLOGIC QDR-3000 X-RAY BONE DENSITOMETER 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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