Cleared Traditional

K901854 - GADOLINIUM-153 BONE DENSITOMETER (GDC.1...

K901854 is the FDA 510(k) clearance for GADOLINIUM-153 BONE DENSITOMETER (GDC.1... by Amersham Corp.. It is a Class 2 Radiology device (product code KGI) cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K901854 · Amersham Corp. · Radiology device
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Jul 1990
Decision
76d
Days
Class 2
Risk

K901854 is an FDA 510(k) clearance for the GADOLINIUM-153 BONE DENSITOMETER (GDC.10411/10412). Classified as Densitometer, Bone (product code KGI), Class II - Special Controls.

Submitted by Amersham Corp. (Arlington Heights, US). The FDA issued a Cleared decision on July 9, 1990 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1170 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Amersham Corp. devices

Submission Details

510(k) Number K901854 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1990
Decision Date July 09, 1990
Days to Decision 76 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 107d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KGI Densitometer, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1170
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - KGI Densitometer, Bone

All 44
Devices cleared under the same product code (KGI) and FDA review panel - the closest regulatory comparables to K901854.
HOLOGIC QDR-1000/W X-RAY BONE DENSITOMETER
K894795 · Hologic, Inc. · Aug 1990
GADOLINIUM-153 BONE DENSITOMETER SOURCES GDC.10415
K901832 · Amersham Corp. · Jul 1990
GADOLINIUM-153 BONE DENSITOMETER SOURCES
K901848 · Amersham Corp. · Jul 1990
GADOLINIUM-153 BONE DENSITOMETER (GDC.10413)
K901857 · Amersham Corp. · Jul 1990
MODIFIED QDR-1000 X-RAY BONE DENSITOMETER
K890999 · Hologic, Inc. · Dec 1989
HOLOGIC QDR-1000 X-RAY BONE DENSITOMETER/MODIFIED
K883280 · Hologic, Inc. · Sep 1988