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FDA 510(k)

LATERAL SPINE OPT. XR-SERIES X-RAY BONE DENSITOMET

K-Number: K913078 · 1991-09-24

ApplicantNorland Corp.
Decision Date1991-09-24
Product CodeKGI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

LATERAL SPINE OPT. XR-SERIES X-RAY BONE DENSITOMET is the device name listed in this FDA 510(k) record. The listed applicant is Norland Corp.. It received FDA 510(k) clearance on 1991-09-24 under 510(k) number K913078. 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 LATERAL SPINE OPT. XR-SERIES X-RAY BONE DENSITOMET?

LATERAL SPINE OPT. XR-SERIES X-RAY BONE DENSITOMET is a medical device that received FDA 510(k) clearance on 1991-09-24. The listed applicant is Norland Corp.. The 510(k) number is K913078.

When did LATERAL SPINE OPT. XR-SERIES X-RAY BONE DENSITOMET receive FDA 510(k) clearance?

LATERAL SPINE OPT. XR-SERIES X-RAY BONE DENSITOMET received FDA 510(k) clearance on 1991-09-24, under 510(k) number K913078.

Who is the listed applicant for LATERAL SPINE OPT. XR-SERIES X-RAY BONE DENSITOMET?

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 LATERAL SPINE OPT. XR-SERIES X-RAY BONE DENSITOMET?

The FDA product code for LATERAL SPINE OPT. XR-SERIES X-RAY BONE DENSITOMET 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.

K980289FRACTURE RISK ASSESSMENT FOR THE NORLAND SXA 3000 BONE DENSITOMETERK980569FRACTURE RISK ASSESSMENT CAPABILITY FOR NORLAND X-RAY BONE DENSITOMETERSK980125REFERENCE 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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