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FDA 510(k)

XR 46 DXA (CENTRAL) BONE DENSITOMETER, MODEL XR 46

K-Number: K992125 · 1999-11-22

ApplicantNorland Medical Systems, Inc.
Decision Date1999-11-22
Product CodeKGI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

XR 46 DXA (CENTRAL) BONE DENSITOMETER, MODEL XR 46 is the device name listed in this FDA 510(k) record. The listed applicant is Norland Medical Systems, Inc.. It received FDA 510(k) clearance on 1999-11-22 under 510(k) number K992125. 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 XR 46 DXA (CENTRAL) BONE DENSITOMETER, MODEL XR 46?

XR 46 DXA (CENTRAL) BONE DENSITOMETER, MODEL XR 46 is a medical device that received FDA 510(k) clearance on 1999-11-22. The listed applicant is Norland Medical Systems, Inc.. The 510(k) number is K992125.

When did XR 46 DXA (CENTRAL) BONE DENSITOMETER, MODEL XR 46 receive FDA 510(k) clearance?

XR 46 DXA (CENTRAL) BONE DENSITOMETER, MODEL XR 46 received FDA 510(k) clearance on 1999-11-22, under 510(k) number K992125.

Who is the listed applicant for XR 46 DXA (CENTRAL) BONE DENSITOMETER, MODEL XR 46?

The FDA 510(k) record lists Norland Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for XR 46 DXA (CENTRAL) BONE DENSITOMETER, MODEL XR 46?

The FDA product code for XR 46 DXA (CENTRAL) BONE DENSITOMETER, MODEL XR 46 is KGI.

Related Clinical Trials

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.

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Other records listing Norland Medical Systems, Inc. as applicant

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.

K993176MULTI-RACIAL REFERENCE POPULATION FOR PDEXA AND DISCOVERYK993337APOLLO MULTI-RACIAL REFERENCE POPULATION

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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