Cleared Traditional

K881865 - NORLAND MODEL XR-26 X-RAY BONE DENSITOMETER

K881865 is an FDA 510(k) clearance for NORLAND MODEL XR-26 X-RAY BONE DENSITOMETER, 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 314-day FDA review.

K881865 · Norland Corp. · Radiology device
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Mar 1989
Decision
314d
Days
Class 2
Risk

K881865 is an FDA 510(k) clearance for the NORLAND MODEL XR-26 X-RAY BONE DENSITOMETER. 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 March 14, 1989 after a review of 314 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 - K881865

510(k) Number K881865 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1988
Decision Date March 14, 1989
Days to Decision 314 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
207d slower than avg
Panel avg: 107d · This submission: 314d
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 K881865.
GADOLINIUM-153 BONE DENSITOMETER (GDC.10411/10412)
K901854 · 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
HOLOGIC MODEL WHF-1 ANTHROPOMORPHIC FEMUR PHANTOM
K883360 · Hologic, Inc. · Sep 1988
HOLOGIC MODELS BLK-1, DPA/QDR-1 & QCT-1
K871446 · Hologic, Inc. · Oct 1987