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Glory Mammographic X-Ray System

by Elscint, Inc.

510(k) K970680

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 NumberK970680 Date20 Jun 1997ClearedStatusActive

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  • Withdrawn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)

Full name
Glory
510(k) Number
FDA Product Code
IZH
Device Class
Class II
Regulation
21 CFR Part 892.1710
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The Glory is a System, X-Ray, Mammographic device, classified under FDA regulation 892.1710. It is designed for digital mammography imaging, providing high-resolution breast imaging to aid in the detection and diagnosis of breast cancer. This Class II medical device incorporates advanced X-ray technology tailored specifically for radiologic examinations of breast tissue, ensuring precise and detailed visualization for clinical assessment.

The Glory system is supplied as a reusable medical device, intended for use in radiology departments within healthcare facilities. It has received FDA 510(k) clearance under the Traditional pathway, demonstrating substantial equivalence to the predicate device MAM-CH22S. The device operates under standard radiologic conditions and requires proper maintenance and calibration to ensure accurate imaging performance. No specific sterility or single-use designation is noted in the regulatory records.

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