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FDA 510(k)

HOLOGIC QDR-1000 X-RAY BONE DENSITOMETER/MODIFIED

K-Number: K883280 · 1988-09-29

ApplicantHologic, Inc.
Decision Date1988-09-29
Product CodeKGI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HOLOGIC QDR-1000 X-RAY BONE DENSITOMETER/MODIFIED is the device name listed in this FDA 510(k) record. The listed applicant is Hologic, Inc.. It received FDA 510(k) clearance on 1988-09-29 under 510(k) number K883280. 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-1000 X-RAY BONE DENSITOMETER/MODIFIED?

HOLOGIC QDR-1000 X-RAY BONE DENSITOMETER/MODIFIED is a medical device that received FDA 510(k) clearance on 1988-09-29. The listed applicant is Hologic, Inc.. The 510(k) number is K883280.

When did HOLOGIC QDR-1000 X-RAY BONE DENSITOMETER/MODIFIED receive FDA 510(k) clearance?

HOLOGIC QDR-1000 X-RAY BONE DENSITOMETER/MODIFIED received FDA 510(k) clearance on 1988-09-29, under 510(k) number K883280.

Who is the listed applicant for HOLOGIC QDR-1000 X-RAY BONE DENSITOMETER/MODIFIED?

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-1000 X-RAY BONE DENSITOMETER/MODIFIED?

The FDA product code for HOLOGIC QDR-1000 X-RAY BONE DENSITOMETER/MODIFIED 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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