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GADOLINIUM-153 Bone Densitometer Sources

by Amersham Corp. 510(k)

Active United States

510(k) K901848

Overview

A Gadolinium-153 Bone Densitometer Source is a radioactive source used in bone densitometry devices to measure bone mineral density. It emits gamma radiation that is detected by the densitometer system to assess bone density, typically for diagnosing osteoporosis and evaluating fracture risk.

This device is supplied as a sealed radioactive source for use in medical imaging facilities. It is intended for use in controlled clinical environments by trained professionals. The source is not sterile, not single-use, and has no stated MRI safety information. It is authorised under FDA 510(k) clearance K901848 as a Class II medical device, with product code KGI and regulation number 892.1170.

AI-generated from registry data, 21 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK901848 Date9 Jul 1990ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
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  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

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

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Questions

  • What is the Gadolinium-153 Bone Densitometer Source used for?

    It is used in bone densitometry devices to emit gamma radiation that is detected by the system to measure bone mineral density, aiding in the diagnosis of osteoporosis and assessment of fracture risk.

  • How is the Gadolinium-153 Bone Densitometer Source supplied and is it sterile or single-use?

    It is supplied as a sealed radioactive source for use in medical imaging facilities; it is not sterile and not intended for single-use, as it is designed for repeated use in controlled clinical environments by trained professionals.

  • What regulatory authorization does the Gadolinium-153 Bone Densitometer Source have?

    It is authorised under FDA 510(k) clearance K901848 as a Class II medical device, with product code KGI and regulation number 892.1170, based on a traditional submission found substantially equivalent.