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QCT-Bone Mineral Analysis Phantom

by Image Analysis Limited

510(k) K941126

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK941126 Date3 May 1995ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
KGI
FDA applicant
Image Analysis, Inc.
Device Class
Class II
Regulation
21 CFR Part 892.1170
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

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

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.

The QCT-Bone Mineral Analysis Phantom (K941126) is a Class II device cleared via FDA 510(k) traditional pathway, with product code KGI and regulation number 892.1170. It is supplied by Image Analysis Limited and was cleared on May 3, 1995, under K941126.

Other devices from Image Analysis Limited

See all devices from Image Analysis Limited →

Questions

AI-generated answers, 21 Sep 2026

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

  • What is the QCT-Bone Mineral Analysis Phantom used for?

    It is a bone densitometer intended to measure bone density and mineral content by transmitting x-rays or gamma rays through bone and adjacent tissues, including signal analysis and display equipment, patient and equipment supports, and accessories.

  • How is the QCT-Bone Mineral Analysis Phantom supplied and what is its model reference?

    It is supplied by Image Analysis Limited under the model reference K941126, which is the FDA 510(k) number associated with its clearance.

  • Is the QCT-Bone Mineral Analysis Phantom a single-use or reusable device?

    As a bone densitometer phantom designed for calibration and quality control, it is intended for repeated use in clinical settings to ensure accurate measurements over time, not for single-use disposal.