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FDA 510(k)

DXAVIEW SPINE AND HIP, MODEL QCT-3D PLUS

K-Number: K031991 · 2003-07-30

ApplicantImage Analysis, Inc.
Decision Date2003-07-30
Product CodeKGI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DXAVIEW SPINE AND HIP, MODEL QCT-3D PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Image Analysis, Inc.. It received FDA 510(k) clearance on 2003-07-30 under 510(k) number K031991. 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 DXAVIEW SPINE AND HIP, MODEL QCT-3D PLUS?

DXAVIEW SPINE AND HIP, MODEL QCT-3D PLUS is a medical device that received FDA 510(k) clearance on 2003-07-30. The listed applicant is Image Analysis, Inc.. The 510(k) number is K031991.

When did DXAVIEW SPINE AND HIP, MODEL QCT-3D PLUS receive FDA 510(k) clearance?

DXAVIEW SPINE AND HIP, MODEL QCT-3D PLUS received FDA 510(k) clearance on 2003-07-30, under 510(k) number K031991.

Who is the listed applicant for DXAVIEW SPINE AND HIP, MODEL QCT-3D PLUS?

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

What is the FDA product code for DXAVIEW SPINE AND HIP, MODEL QCT-3D PLUS?

The FDA product code for DXAVIEW SPINE AND HIP, MODEL QCT-3D PLUS is KGI.

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Other records listing Image Analysis, 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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