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FDA 510(k)

METRISCAN BONE DENSITY SYSTEM

K-Number: K000162 · 2000-05-12

ApplicantAlara, Inc.
Decision Date2000-05-12
Product CodeKGI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

METRISCAN BONE DENSITY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Alara, Inc.. It received FDA 510(k) clearance on 2000-05-12 under 510(k) number K000162. 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 METRISCAN BONE DENSITY SYSTEM?

METRISCAN BONE DENSITY SYSTEM is a medical device that received FDA 510(k) clearance on 2000-05-12. The listed applicant is Alara, Inc.. The 510(k) number is K000162.

When did METRISCAN BONE DENSITY SYSTEM receive FDA 510(k) clearance?

METRISCAN BONE DENSITY SYSTEM received FDA 510(k) clearance on 2000-05-12, under 510(k) number K000162.

Who is the listed applicant for METRISCAN BONE DENSITY SYSTEM?

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

What is the FDA product code for METRISCAN BONE DENSITY SYSTEM?

The FDA product code for METRISCAN BONE DENSITY SYSTEM 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.

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Other records listing Alara, Inc. 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.

K102479ALARA T210 COMPUTED RADIOGRAPHY SYSTEMK071682CRYSTALVIEW T-SERIES COMPUTED RADIOGRAPHY SYSTEM, MODELS T110 (WITH ERASER) AND T100 (WITHOUT ERASER)K062390CRYSTALVIEW R200K061538ALARA CRYSTALVIEW COMPUTED RADIOGRAPHY SYSTEM, MODEL R200K032210ALARA CRYSTALVIEW COMPUTED RADIOGRAPHY SYSTEM

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

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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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