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FDA 510(k)

DPX-L AND DPX-ALPHA, MODIFICATION

K-Number: K904980 · 1990-12-05

ApplicantLunar
Decision Date1990-12-05
Product CodeKGI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DPX-L AND DPX-ALPHA, MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Lunar. It received FDA 510(k) clearance on 1990-12-05 under 510(k) number K904980. 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-L AND DPX-ALPHA, MODIFICATION?

DPX-L AND DPX-ALPHA, MODIFICATION is a medical device that received FDA 510(k) clearance on 1990-12-05. The listed applicant is Lunar. The 510(k) number is K904980.

When did DPX-L AND DPX-ALPHA, MODIFICATION receive FDA 510(k) clearance?

DPX-L AND DPX-ALPHA, MODIFICATION received FDA 510(k) clearance on 1990-12-05, under 510(k) number K904980.

Who is the listed applicant for DPX-L AND DPX-ALPHA, MODIFICATION?

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 DPX-L AND DPX-ALPHA, MODIFICATION?

The FDA product code for DPX-L AND DPX-ALPHA, MODIFICATION 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-ALPHAK890121MODIFIED DPX BONE DENSITOMETERK884625DPX 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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