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FDA 510(k)

DPX BONE DENSITOMETER FOR TOTAL BODY BONE DENSITY

K-Number: K884625 · 1989-06-23

ApplicantLunar
Decision Date1989-06-23
Product CodeKGI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DPX BONE DENSITOMETER FOR TOTAL BODY BONE DENSITY is the device name listed in this FDA 510(k) record. The listed applicant is Lunar. It received FDA 510(k) clearance on 1989-06-23 under 510(k) number K884625. 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 BONE DENSITOMETER FOR TOTAL BODY BONE DENSITY?

DPX BONE DENSITOMETER FOR TOTAL BODY BONE DENSITY is a medical device that received FDA 510(k) clearance on 1989-06-23. The listed applicant is Lunar. The 510(k) number is K884625.

When did DPX BONE DENSITOMETER FOR TOTAL BODY BONE DENSITY receive FDA 510(k) clearance?

DPX BONE DENSITOMETER FOR TOTAL BODY BONE DENSITY received FDA 510(k) clearance on 1989-06-23, under 510(k) number K884625.

Who is the listed applicant for DPX BONE DENSITOMETER FOR TOTAL BODY BONE DENSITY?

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 BONE DENSITOMETER FOR TOTAL BODY BONE DENSITY?

The FDA product code for DPX BONE DENSITOMETER FOR TOTAL BODY BONE DENSITY 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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, MODIFICATIONK890121MODIFIED DPX BONE DENSITOMETER

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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