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FDA 510(k)

FOREARM SOFTWARE FOR LUNAR DPX SERIES BONE DESITOM

K-Number: K915535 · 1992-02-27

ApplicantLunar
Decision Date1992-02-27
Product CodeKGI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FOREARM SOFTWARE FOR LUNAR DPX SERIES BONE DESITOM is the device name listed in this FDA 510(k) record. The listed applicant is Lunar. It received FDA 510(k) clearance on 1992-02-27 under 510(k) number K915535. 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 FOREARM SOFTWARE FOR LUNAR DPX SERIES BONE DESITOM?

FOREARM SOFTWARE FOR LUNAR DPX SERIES BONE DESITOM is a medical device that received FDA 510(k) clearance on 1992-02-27. The listed applicant is Lunar. The 510(k) number is K915535.

When did FOREARM SOFTWARE FOR LUNAR DPX SERIES BONE DESITOM receive FDA 510(k) clearance?

FOREARM SOFTWARE FOR LUNAR DPX SERIES BONE DESITOM received FDA 510(k) clearance on 1992-02-27, under 510(k) number K915535.

Who is the listed applicant for FOREARM SOFTWARE FOR LUNAR DPX SERIES BONE DESITOM?

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 FOREARM SOFTWARE FOR LUNAR DPX SERIES BONE DESITOM?

The FDA product code for FOREARM SOFTWARE FOR LUNAR DPX SERIES BONE DESITOM 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-@ DESITK905291LATERAL SPINE DETERMAINATIONS DPX/DPX-L/DPX-ALPHAK904980DPX-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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