510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K901832Substantially Equivalent

Gadolinium-153 Bone Densitometer Sources Gdc.10415

Amersham Corp., Arlington Heights IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K901832 is the FDA 510(k) clearance record for GADOLINIUM-153 BONE DENSITOMETER SOURCES GDC.10415, a class II device, cleared for Amersham Corp. on under FDA product code KGI (Densitometer, Bone). FDA records list 94 510(k) clearances for Amersham Corp., from to . As of , FDA records show no recalls naming K901832.

Clearance record

Decision date
Received
(76 days to decision)
Product code
KGI Densitometer, Bone
Regulation
21 CFR 892.1170
Device class
Class II
Review panel
Radiology
Applicant
Amersham Corp. 2636 S. Clearbrook Dr., Arlington Heights IL
Third party review
No

Clearances, product code KGI

Trailing 12 months
2 clearances under product code KGI in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KGI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260