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FDA 510(k)

GE LUNAR DPX & PRODIGY SERIES DEXA BONE DENSITOMETERS WITH MOBILE KIT

K-Number: K072439 · 2007-09-14

Decision Date2007-09-14
Product CodeKGI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GE LUNAR DPX & PRODIGY SERIES DEXA BONE DENSITOMETERS WITH MOBILE KIT 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 2007-09-14 under 510(k) number K072439. 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 DPX & PRODIGY SERIES DEXA BONE DENSITOMETERS WITH MOBILE KIT?

GE LUNAR DPX & PRODIGY SERIES DEXA BONE DENSITOMETERS WITH MOBILE KIT is a medical device that received FDA 510(k) clearance on 2007-09-14. The listed applicant is Ge Medical Systems Ultrasound and Primary Care Dia. The 510(k) number is K072439.

When did GE LUNAR DPX & PRODIGY SERIES DEXA BONE DENSITOMETERS WITH MOBILE KIT receive FDA 510(k) clearance?

GE LUNAR DPX & PRODIGY SERIES DEXA BONE DENSITOMETERS WITH MOBILE KIT received FDA 510(k) clearance on 2007-09-14, under 510(k) number K072439.

Who is the listed applicant for GE LUNAR DPX & PRODIGY SERIES DEXA BONE DENSITOMETERS WITH MOBILE KIT?

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 DPX & PRODIGY SERIES DEXA BONE DENSITOMETERS WITH MOBILE KIT?

The FDA product code for GE LUNAR DPX & PRODIGY SERIES DEXA BONE DENSITOMETERS WITH MOBILE KIT 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.

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.

View all 7 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.

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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