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FDA 510(k)

DUAL-ENERGY VERTEBRAL ASSESSMENT VIEW SOFTWARE

K-Number: K023554 · 2002-12-20

ApplicantGe Lunar Corp.
Decision Date2002-12-20
Product CodeKGI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DUAL-ENERGY VERTEBRAL ASSESSMENT VIEW SOFTWARE is the device name listed in this FDA 510(k) record. The listed applicant is Ge Lunar Corp.. It received FDA 510(k) clearance on 2002-12-20 under 510(k) number K023554. 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 DUAL-ENERGY VERTEBRAL ASSESSMENT VIEW SOFTWARE?

DUAL-ENERGY VERTEBRAL ASSESSMENT VIEW SOFTWARE is a medical device that received FDA 510(k) clearance on 2002-12-20. The listed applicant is Ge Lunar Corp.. The 510(k) number is K023554.

When did DUAL-ENERGY VERTEBRAL ASSESSMENT VIEW SOFTWARE receive FDA 510(k) clearance?

DUAL-ENERGY VERTEBRAL ASSESSMENT VIEW SOFTWARE received FDA 510(k) clearance on 2002-12-20, under 510(k) number K023554.

Who is the listed applicant for DUAL-ENERGY VERTEBRAL ASSESSMENT VIEW SOFTWARE?

The FDA 510(k) record lists Ge Lunar Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DUAL-ENERGY VERTEBRAL ASSESSMENT VIEW SOFTWARE?

The FDA product code for DUAL-ENERGY VERTEBRAL ASSESSMENT VIEW SOFTWARE 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 Ge Lunar Corp. 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.

K030962DPX SERIES BRAVO DUO BONE DENSITOMETERK011917ADVANCED HIP ASSESSMENT SOFTWARE

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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