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Sahara Clinical Bone Sonometer

by Hologic, Inc.

PMA P970017

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

PMA P970017↗

FDA record

Trust

Unverified

Source FDA PMA, synced 6 Oct 2026.

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPRL NumberP970017 Date12 Mar 1998DecidedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Generic name
Bone sonometer
PMA number
FDA product code
MUA
Device class
Class II
Regulation
21 CFR Part 892.1180
Advisory committee
Radiology
FDA decision
APRL

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Sahara Clinical Bone Sonometer is a quantitative ultrasound device classified as a bone sonometer, designed to measure bone density. It assesses the calcaneus (heel bone) by determining the speed of sound (SOS) and broadband ultrasonic attenuation (BUA), then calculates the Quantitative Ultrasound Index (QUI), T-score, and estimated Bone Mineral Density (BMD) in g/cm² for fracture risk assessment.

This device is used in radiology settings to aid physicians in diagnosing osteoporosis and related conditions affecting bone density. Supplied as a reusable medical instrument, it requires FDA_PMA authorization (PMA P970017) and is regulated under product code MUA. No specific sterility or MRI safety details are provided in the data.

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