Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

GE LUNAR FRAX 10-YEAR FRACTURE RISK SOFTWARE OPTION

K-Number: K082317 · 2008-09-26

ApplicantGeneral Electric Co.
Decision Date2008-09-26
Product CodeKGI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GE LUNAR FRAX 10-YEAR FRACTURE RISK SOFTWARE OPTION is the device name listed in this FDA 510(k) record. The listed applicant is General Electric Co.. It received FDA 510(k) clearance on 2008-09-26 under 510(k) number K082317. 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 GE LUNAR FRAX 10-YEAR FRACTURE RISK SOFTWARE OPTION?

GE LUNAR FRAX 10-YEAR FRACTURE RISK SOFTWARE OPTION is a medical device that received FDA 510(k) clearance on 2008-09-26. The listed applicant is General Electric Co.. The 510(k) number is K082317.

When did GE LUNAR FRAX 10-YEAR FRACTURE RISK SOFTWARE OPTION receive FDA 510(k) clearance?

GE LUNAR FRAX 10-YEAR FRACTURE RISK SOFTWARE OPTION received FDA 510(k) clearance on 2008-09-26, under 510(k) number K082317.

Who is the listed applicant for GE LUNAR FRAX 10-YEAR FRACTURE RISK SOFTWARE OPTION?

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

What is the FDA product code for GE LUNAR FRAX 10-YEAR FRACTURE RISK SOFTWARE OPTION?

The FDA product code for GE LUNAR FRAX 10-YEAR FRACTURE RISK SOFTWARE OPTION 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 General Electric Co. 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.

K103489GE VEO RECONSTRUCTION OPTIONK081921GE VIVID E9 ULTRASOUNDK073297GE LOGIQ P6K072952GE ECHOPACK072797GE LOGIQ I COMAPACT ULTRASOUND, GE LOGIQ E COMPACT ULTRASOUND, GE VIVID E COMPACT ULTRASOUNDK072075MODIFICATION TO GE LOGIQ A3

View all 254 devices →

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.

↑