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Achilles Express Ultrasonometer

by Ge Lunar Corp.

PMA P970040

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None ongoing

2 closed

Documents

PMA P970040↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPRL NumberP970040 Date26 Jun 1998DecidedStatusActive

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0112-2020 FDA Class II initiated 3 Sep 2019
    • Terminated Z-0113-2020 FDA Class II initiated 3 Sep 2019

    Certain Achilles Express and Achilles Insight systems were shipped with European CEE-7/7 Type Power Cords to countries where three protruding pin plugs are required for protective earth connection.

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  • Withdrawn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 Achilles Express Ultrasonometer is a bone sonometer classified under the nomenclature for measuring ultrasound variables of the os calcis. It quantifies the Stiffness Index, a clinical metric used to assess fracture risk in postmenopausal women, providing a comparable alternative to bone mineral density (BMD) measurements via X-ray absorptiometry.

This device is used in radiology settings to generate Stiffness Index T-scores, aiding physicians in osteoporosis diagnosis alongside other clinical risk factors. Supplied as a reusable instrument, it operates under FDA Premarket Approval (PMA) with PMA number P970040. The device’s precision aligns with that of X-ray absorptiometry, enabling longitudinal monitoring of bone changes.

Other devices from Ge Lunar Corp.