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FDA 510(k)

ORCA-DX BONE DENSITOMETER

K-Number: K983724 · 1998-12-08

ApplicantLunar Corp.
Decision Date1998-12-08
Product CodeKGI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ORCA-DX 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 1998-12-08 under 510(k) number K983724. 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 ORCA-DX BONE DENSITOMETER?

ORCA-DX BONE DENSITOMETER is a medical device that received FDA 510(k) clearance on 1998-12-08. The listed applicant is Lunar Corp.. The 510(k) number is K983724.

When did ORCA-DX BONE DENSITOMETER receive FDA 510(k) clearance?

ORCA-DX BONE DENSITOMETER received FDA 510(k) clearance on 1998-12-08, under 510(k) number K983724.

Who is the listed applicant for ORCA-DX 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 ORCA-DX BONE DENSITOMETER?

The FDA product code for ORCA-DX 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 SOFTWAREK983262FRACTURE RISK ASSESSMENT OPTION FOR PIXI BONE DENSITOMETERSK983271FRACTURE 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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