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FDA 510(k)

BONE DENSITOMETER

K-Number: K841463 · 1984-07-17

ApplicantNorland Corp.
Decision Date1984-07-17
Product CodeKGI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BONE DENSITOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Norland Corp.. It received FDA 510(k) clearance on 1984-07-17 under 510(k) number K841463. 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 BONE DENSITOMETER?

BONE DENSITOMETER is a medical device that received FDA 510(k) clearance on 1984-07-17. The listed applicant is Norland Corp.. The 510(k) number is K841463.

When did BONE DENSITOMETER receive FDA 510(k) clearance?

BONE DENSITOMETER received FDA 510(k) clearance on 1984-07-17, under 510(k) number K841463.

Who is the listed applicant for BONE DENSITOMETER?

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

What is the FDA product code for BONE DENSITOMETER?

The FDA product code for BONE DENSITOMETER is KGI.

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Other records listing Norland 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.

K980569FRACTURE RISK ASSESSMENT CAPABILITY FOR NORLAND X-RAY BONE DENSITOMETERSK980289FRACTURE RISK ASSESSMENT FOR THE NORLAND SXA 3000 BONE DENSITOMETERK980125REFERENCE POPULATION FOR NORLAND APOLLO X-RAY BONE DENSITOMETERK973459NORLAND BODY COMPOSITION OPTION FOR NORLAND DEXA BONE DENSITOMETERSK973104NORLAND MODEL PDEXA BONE DENSITOMETERK972882APOLLO

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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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