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FDA 510(k)

MODIFIED DPX BONE DENSITOMETER

K-Number: K890121 · 1990-04-10

ApplicantLunar
Decision Date1990-04-10
Product CodeKGI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MODIFIED DPX BONE DENSITOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Lunar. It received FDA 510(k) clearance on 1990-04-10 under 510(k) number K890121. 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 MODIFIED DPX BONE DENSITOMETER?

MODIFIED DPX BONE DENSITOMETER is a medical device that received FDA 510(k) clearance on 1990-04-10. The listed applicant is Lunar. The 510(k) number is K890121.

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

MODIFIED DPX BONE DENSITOMETER received FDA 510(k) clearance on 1990-04-10, under 510(k) number K890121.

Who is the listed applicant for MODIFIED DPX BONE DENSITOMETER?

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

What is the FDA product code for MODIFIED DPX BONE DENSITOMETER?

The FDA product code for MODIFIED DPX BONE DENSITOMETER 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 Lunar 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.

K914404ORTHO SOFTWARE USED W/LUNAR DPX/DPX-L/DPS-@ DESITK915535FOREARM SOFTWARE FOR LUNAR DPX SERIES BONE DESITOMK905291LATERAL SPINE DETERMAINATIONS DPX/DPX-L/DPX-ALPHAK904980DPX-L AND DPX-ALPHA, MODIFICATIONK884625DPX BONE DENSITOMETER FOR TOTAL BODY BONE DENSITY

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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