Cleared Traditional

GADOLINIUM-153 BONE DENSITOMETER (GDC.10411/10412)

K901854 · Amersham Corp. · Radiology

Jul 1990

Decision

76d

Days

Class 2

Risk

About This 510(k) Submission

K901854 is an FDA 510(k) clearance for the GADOLINIUM-153 BONE DENSITOMETER (GDC.10411/10412), a Densitometer, Bone (Class II — Special Controls, product code KGI), submitted by Amersham Corp. (Arlington Heights, US). The FDA issued a Cleared decision on July 9, 1990, 76 days after receiving the submission on April 24, 1990. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1170.

Submission Details

510(k) Number	K901854 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 24, 1990
Decision Date	July 09, 1990
Days to Decision	76 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	—