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FDA 510(k)

EXPANDED REFERENCE VALUES FOR DPX BON DENSITOMETERS

K-Number: K964307 · 1997-04-16

ApplicantLunar Corp.
Decision Date1997-04-16
Product CodeKGI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EXPANDED REFERENCE VALUES FOR DPX BON DENSITOMETERS is the device name listed in this FDA 510(k) record. The listed applicant is Lunar Corp.. It received FDA 510(k) clearance on 1997-04-16 under 510(k) number K964307. 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 EXPANDED REFERENCE VALUES FOR DPX BON DENSITOMETERS?

EXPANDED REFERENCE VALUES FOR DPX BON DENSITOMETERS is a medical device that received FDA 510(k) clearance on 1997-04-16. The listed applicant is Lunar Corp.. The 510(k) number is K964307.

When did EXPANDED REFERENCE VALUES FOR DPX BON DENSITOMETERS receive FDA 510(k) clearance?

EXPANDED REFERENCE VALUES FOR DPX BON DENSITOMETERS received FDA 510(k) clearance on 1997-04-16, under 510(k) number K964307.

Who is the listed applicant for EXPANDED REFERENCE VALUES FOR DPX BON DENSITOMETERS?

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

What is the FDA product code for EXPANDED REFERENCE VALUES FOR DPX BON DENSITOMETERS?

The FDA product code for EXPANDED REFERENCE VALUES FOR DPX BON DENSITOMETERS is KGI.

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Other records listing Lunar Corp. 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.

K001812PEDIATRIC REFERENCE DATAK001756LUNAR REPORT GENERATOR IIK000826PRODIGY LATERAL VIEW SOFTWAREK983564PRODIGY TOTAL BODY SOFTWAREK983724ORCA-DX BONE DENSITOMETERK983269FRACTURE RISK ASSESSMENT OPTION FOR EXPERT-XL BONE DENSITOMETER

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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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