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FDA 510(k)

GE LUNAR VISCERAL FAT SOFTWARE

K-Number: K103730 · 2011-05-06

ApplicantGe Medical Systems Ultrasound and Primary Care Dia
Decision Date2011-05-06
Product CodeKGI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GE LUNAR VISCERAL FAT SOFTWARE 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 2011-05-06 under 510(k) number K103730. 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 VISCERAL FAT SOFTWARE?

GE LUNAR VISCERAL FAT SOFTWARE is a medical device that received FDA 510(k) clearance on 2011-05-06. The listed applicant is Ge Medical Systems Ultrasound and Primary Care Dia. The 510(k) number is K103730.

When did GE LUNAR VISCERAL FAT SOFTWARE receive FDA 510(k) clearance?

GE LUNAR VISCERAL FAT SOFTWARE received FDA 510(k) clearance on 2011-05-06, under 510(k) number K103730.

Who is the listed applicant for GE LUNAR VISCERAL FAT SOFTWARE?

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 GE LUNAR VISCERAL FAT SOFTWARE?

The FDA product code for GE LUNAR VISCERAL FAT SOFTWARE is KGI.

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Other records listing Ge Medical Systems Ultrasound and Primary Care Dia 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.

K072664GE LUNAR FEMUR STRENGTH SOFTWAREK082185GE LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM, MODELS 5205000, 5205000-2K073408GE LOGIQ BT08 DIAGNOSTIC ULTRASOUND SYSTEMK072439GE LUNAR DPX & PRODIGY SERIES DEXA BONE DENSITOMETERS WITH MOBILE KITK052581LUNAR IDXAK041813GE LOGIQ 7 ULTRASOUND BT04

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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.

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