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FDA 510(k)

LATERAL SPINE DETERMAINATIONS DPX/DPX-L/DPX-ALPHA

K-Number: K905291 · 1991-08-09

ApplicantLunar
Decision Date1991-08-09
Product CodeKGI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

LATERAL SPINE DETERMAINATIONS DPX/DPX-L/DPX-ALPHA is the device name listed in this FDA 510(k) record. The listed applicant is Lunar. It received FDA 510(k) clearance on 1991-08-09 under 510(k) number K905291. 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 LATERAL SPINE DETERMAINATIONS DPX/DPX-L/DPX-ALPHA?

LATERAL SPINE DETERMAINATIONS DPX/DPX-L/DPX-ALPHA is a medical device that received FDA 510(k) clearance on 1991-08-09. The listed applicant is Lunar. The 510(k) number is K905291.

When did LATERAL SPINE DETERMAINATIONS DPX/DPX-L/DPX-ALPHA receive FDA 510(k) clearance?

LATERAL SPINE DETERMAINATIONS DPX/DPX-L/DPX-ALPHA received FDA 510(k) clearance on 1991-08-09, under 510(k) number K905291.

Who is the listed applicant for LATERAL SPINE DETERMAINATIONS DPX/DPX-L/DPX-ALPHA?

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 LATERAL SPINE DETERMAINATIONS DPX/DPX-L/DPX-ALPHA?

The FDA product code for LATERAL SPINE DETERMAINATIONS DPX/DPX-L/DPX-ALPHA 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 DESITOMK904980DPX-L AND DPX-ALPHA, MODIFICATIONK890121MODIFIED 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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