FDA 510(k)

LUNAR IDXA

K-Number: K052581 · 2005-10-20

ApplicantGe Medical Systems Ultrasound and Primary Care Dia

Decision Date2005-10-20

Product CodeKGI

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

LUNAR IDXA is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems Ultrasound and Primary Care Dia. It received FDA 510(k) clearance on 2005-10-20 under 510(k) number K052581. 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 LUNAR IDXA?

LUNAR IDXA is a medical device that received FDA 510(k) clearance on 2005-10-20. The listed applicant is Ge Medical Systems Ultrasound and Primary Care Dia. The 510(k) number is K052581.

When did LUNAR IDXA receive FDA 510(k) clearance?

LUNAR IDXA received FDA 510(k) clearance on 2005-10-20, under 510(k) number K052581.

Who is the listed applicant for LUNAR IDXA?

The FDA 510(k) record lists Ge Medical Systems Ultrasound and Primary Care Dia as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LUNAR IDXA?

The FDA product code for LUNAR IDXA 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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Ge Medical Systems Ultrasound and Primary Care Dia as applicant

K103730GE LUNAR VISCERAL FAT SOFTWARE K072664GE LUNAR FEMUR STRENGTH SOFTWARE K082185GE LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM, MODELS 5205000, 5205000-2 K073408GE LOGIQ BT08 DIAGNOSTIC ULTRASOUND SYSTEM K072439GE LUNAR DPX & PRODIGY SERIES DEXA BONE DENSITOMETERS WITH MOBILE KIT K041813GE LOGIQ 7 ULTRASOUND BT04

View all 7 devices →

Related Devices (Code: KGI)

K254072BoneVueCurvebeam AI / Curvebeam, LLC K252718Lunar AstraGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC K2510223D-SHAPER3D-Shaper Medical S.L K242295BunkerHill BMDBunkerHill Health K243218TBS iNsight (V4)Medimaps Group SA K220402VirtuOstO.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.