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FDA 510(k)

DPX-RX BONE DENSITOMETER

K-Number: K982267 · 1998-08-18

ApplicantLunar Corp.
Decision Date1998-08-18
Product CodeKGI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DPX-RX BONE DENSITOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Lunar Corp.. It received FDA 510(k) clearance on 1998-08-18 under 510(k) number K982267. 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 DPX-RX BONE DENSITOMETER?

DPX-RX BONE DENSITOMETER is a medical device that received FDA 510(k) clearance on 1998-08-18. The listed applicant is Lunar Corp.. The 510(k) number is K982267.

When did DPX-RX BONE DENSITOMETER receive FDA 510(k) clearance?

DPX-RX BONE DENSITOMETER received FDA 510(k) clearance on 1998-08-18, under 510(k) number K982267.

Who is the listed applicant for DPX-RX BONE DENSITOMETER?

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

What is the FDA product code for DPX-RX BONE DENSITOMETER?

The FDA product code for DPX-RX BONE DENSITOMETER is KGI.

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Other records listing 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.

K001812PEDIATRIC REFERENCE DATAK001756LUNAR REPORT GENERATOR IIK000826PRODIGY LATERAL VIEW SOFTWAREK983564PRODIGY TOTAL BODY SOFTWAREK983724ORCA-DX BONE DENSITOMETERK983271FRACTURE RISK ASSESSMENT OPTION FOR DPX SERIES BONE DENSITOMETERS

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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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