Cleared Traditional

K901804 - NORLAND XR26 WHOLE BODY OPTION

K901804 is an FDA 510(k) clearance for NORLAND XR26 WHOLE BODY OPTION, manufactured by Norland Corp.. The device is a Class 2 Radiology device with product code KGI cleared through the Traditional 510(k) pathway after a 374-day FDA review.

K901804 · Norland Corp. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1991
Decision
374d
Days
Class 2
Risk

K901804 is an FDA 510(k) clearance for the NORLAND XR26 WHOLE BODY OPTION. Classified as Densitometer, Bone (product code KGI), Class II - Special Controls.

Submitted by Norland Corp. (Fort Atkinson, US). The FDA issued a Cleared decision on April 29, 1991 after a review of 374 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Norland Corp. devices

FDA 510(k) Submission Details - K901804

510(k) Number K901804 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 1990
Decision Date April 29, 1991
Days to Decision 374 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
267d slower than avg
Panel avg: 107d · This submission: 374d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KGI Device Classification - Class 2, Special Controls

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 70
Devices cleared under the same product code (KGI) and FDA review panel - the closest regulatory comparables to K901804.
HOLOGIC QDR-2000 X-RAY BONE DENSITOMETER
K913321 · Hologic, Inc. · Nov 1991
QDR-1000 AND QDR-1000/W X-RAY BONE DENSITOMETER
K905753 · Hologic, Inc. · Jun 1991
QDR-1000 AND WITH X-RAY BONE DENSITOMETER
K905691 · Hologic, Inc. · May 1991
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