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K Number
K000162
Device Name
METRISCAN BONE DENSITY SYSTEM
Manufacturer
ALARA, INC.
Date Cleared
2000-05-12

(114 days)

Product Code
KGI
Regulation Number
892.1170
Type
Traditional
Panel
RA
Reference & Predicate Devices
N/A
Predicate For
K113616
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 892.1170 Bone densitometer.

(a)
Identification. A bone densitometer is a device intended for medical purposes to measure bone density and mineral content by x-ray or gamma ray transmission measurements through the bone and adjacent tissues. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.